Acetylsalicylic acid for Breast cancer | Colon cancer | Rectal cancer | Stomach cancer | Oesophageal cancer | Prostate cancer

Inclusion criteria

• {"criterion_text":"- Breast cohort: 1.\tMen or women with histologically confirmed invasive breast cancer. a.\tPatients with synchronous unilateral breast tumours are eligible based on the characteristics of the highest staged tumour. 2.\tPatients have undergone complete primary invasive tumour excision with clear radial margins as judged by the multidisciplinary team. 3.\tSurgical staging of the axilla must have been undertaken by sentinel node biopsy, axillary sampling or dissection. 4.\tIn those patients with a positive sentinel node biopsy: a.\tIf 1, 2 or 3 nodes are positive, subsequent management of the axilla (with surgery, radiotherapy or no further intervention) should follow institutional policy. If axillary surgery is to be undertaken, this should be completed prior to registration. b.\tIf 4 or more nodes are involved, patients must have undergone completion axillary node dissection. 5.\tRadiotherapy: a.\tPatients who have undergone breast-conserving surgery should receive adjuvant radiotherapy. b.\tPatients who have undergone mastectomy should receive radiotherapy if they have more than 3 axillary lymph nodes involved. c.\tPatients who have undergone mastectomy and have T3 tumours and/or 1, 2 or 3 involved lymph nodes may (or not) receive radiation as per institutional practice. 6.\tFinal histology must fall within at least one of these groups: a.\tFor patients not receiving neoadjuvant chemotherapy: i.\tNode positive, or, ii.\tNode negative with high-risk features, defined as two or more of: \tER negative (Allred score <3/8 or negative according to institutional criteria) \tHER2 positive \tGrade 3 \tLymphovascular invasion present \tAge less than 35 \tOncotype Dx score of >25 \tProsignia score (PAM50) of >60 -Patients are permitted to have had neoadjuvant endocrine therapy for up to 6 months, as long as final surgical pathology falls within one of the above two groups. -In the above definitions patients with micrometastases should be regarded as node positive. Patients with isolated tumour cells should be regarded as node negative. b.\tPatients who have received neo-adjuvant chemotherapy or radiotherapy must fall into one of the following 3 categories: i.\tHormone receptor negative and HER2 negative tumour AND has not achieved a pathological complete response, or, ii.\tA HER2 positive tumour (any hormone receptor status) AND not achieved a pathological complete response, or, iii.\tA hormone receptor positive, HER2 negative tumour which is grade 3 AND has not achieved a pathological complete response. 7.\tPatients who received standard neo-adjuvant and/or adjuvant chemotherapy or radiotherapy are eligible. Timing of registration and starting run-in treatment in terms of the treatment pathway should be as described in section 4.2. (For confirmation of standard therapy, please contact MRC CTU at UCL). 8.\tKnown HER2 and ER status. 9.\tNo clinical or radiological evidence of residual or distant disease according to routine practice staging tests. 10.\tParticipants may receive endocrine therapy, trastuzumab and be planned to receive neratinib according to standard practice concomitant with trial participation. All participants with ER positive disease should be planned to undergo a minimum of 5 years of adjuvant endocrine therapy using standard agents or as part of an agreed trial. 11.\tPatients who are already participating (or have participated) in other primary treatment trials may be eligible but this must be agreed in advance with the relevant trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. If a potential participant is enrolled in a trial that is not listed, this should be discussed with the MRC CTU at UCL or TMC (India) prior to registration. 12.\tWHO performance status 0, 1 or 2. 13.\tWritten informed consent."}
• {"criterion_text":"- Colorectal cohort: 1.\tHistologically confirmed, stage II or stage III (see appendix IV) adenocarcinoma of the colon or rectum* and patients who have undergone resection of liver metastases (at any time) with clear margins and no residual metastatic disease as judged by the multidisciplinary team 2.\tPatients with synchronous colorectal tumours if one of the tumours is at least stage II or III. 3.\tSerum CEA ideally ≤1.5 x upper limit of normal (ULN). Participants outside of this range should be discussed with the MRC CTU at UCL on an individual basis. 4.\tHave undergone curative (R0) resection with clear margins (margins ≥1mm or as judged by the multidisciplinary team). 5.\tPatients who have received standard neo-adjuvant and/or adjuvant treatment or therapy within an agreed trial. Timing of registration and starting run-in treatmentin terms of the treatment pathway should be as described in section 4.2. (For confirmation of standard therapy, please contact MRC CTU at UCL). 6.\tNo clinical or radiological evidence of residual or distant disease according to routine practice staging tests. 7.\tPatients with known Lynch Syndrome are eligible.** 8.\tPatients who are already participating (or have participated) in other primary treatment trials may be eligible but this must be agreed in advance with the relevant trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. If a potential participant is enrolled in a trial that is not listed, this should be discussed with the MRC CTU at UCL or TMC (India) prior to registration. 9.\tWHO performance status 0, 1 or 2. 10.\tWritten informed consent."}
• {"criterion_text":"- Gastro-oesophageal cohort: 1.\tPatients with histologically confirmed adenocarcinoma, adenosquamous carcinoma or squamous cell cancer of the oesophagus, gastro-oesophageal junction or stomach. 2.\tPatients will have undergone treatment with curative intent, either: (i) surgery, (ii) radical chemoradiotherapy, (iii) salvage surgery following recurrence after radical chemoradiotherapy or (iv) neo-adjuvant chemoradiotherapy followed by surgery. 3.\tPatients who have undergone surgery with curative intent must have either: a.\tA curative (R0) resection with clear margins (margin ≥1mm or as judged by the multidisciplinary team). b.\tAn R1 resection with circumferential margin microscopically positive within 1mm in patients who have undergone an oesophagectomy or oesophagogastrectomy. 4.\tPatients with M1 nodal disease, where the involved lymph nodes have been encompassed within a radical radiotherapy field, are eligible. 5.\tPatients who have received standard neo-adjuvant and/or adjuvant treatment or therapy within an agreed trial are eligible. Timing of registration and starting run-in treatment in terms of the treatment pathway should be as described in section 4.2. (For confirmation of standard therapy, please contact MRC CTU at UCL). 6.\tNo clinical or radiological evidence of residual or distant disease according to routine practice staging tests. 7.\tIn the UK and Republic of Ireland: Those who have undergone a partial gastrectomy or oesophagectomy should be prescribed a proton pump inhibitor for the duration of the trial where no clinical contraindication exists. 8.\tPatients who are already participating (or have participated) in other primary treatment trials may be eligible but this must be agreed in advance with the relevant trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. If a potential participant is enrolled in a trial that is not listed, this should be discussed with the MRC CTU at UCL. 9.\tWHO performance status 0, 1 or 2. 10.\tWritten informed consent."}
• {"criterion_text":"- Prostate cohort: 1.\tMen with histologically confirmed, node negative, non-metastatic adenocarcinoma, with clinical or radiological stagingof the prostate T1-3b, N0. See appendix VII for TNM staging definitions. 2.\tHave undergone curative treatment, either a.\tRadical prostatectomy. b.\tRadical radiotherapy (external beam or brachytherapy). c.\tSalvage radiotherapy following a rise in PSA after radical prostatectomy. 3.\tIntermediate or high risk according to D’Amico classification93 (prior to radical treatment, see table 3). Also, patients who are low risk prior to prostatectomy but whose prostatectomy histology shows upstaging up to pT3b, or a higher Gleason score of 7 or greater are also eligible, including those with microscopic N1 disease provided any additional ADT is not planned for more than 3 years. 4.\tWHO performance status 0, 1 or 2. 5.\tWritten informed consent. Depending on the curative treatment pathway, participants must additionally satisfy the following: (a)\tProstatectomy patients 6.\tOpen, laparoscopic or robotic radical prostatectomy. 7.\t a.\tMen treated with immediate adjuvant radiotherapy are eligible. Timing of registration and starting run-in treatment in terms of the treatment pathway should be as described in section 4.2. b.\tIn men entering following surgery without adjuvant radiotherapy, PSA at 6-weeks post-surgery should be ≤0.1ng/ml and should remain at this level at the time of entry into the trial, with timing of entry as described in section 4.2. For Indian participants registering before 6 weeks, PSA ≤0.1ng/ml should be confirmed at the time of randomisation. 8.\tMen receiving neo-adjuvant and/or adjuvant hormone therapy (LHRH agonists, LHRH antagonists, bicalutamide monotherapy) are eligible, provided the planned duration of adjuvant therapy is a maximum of three years. Treatment can be ongoing at the time of registration/randomisation to Add-Aspirin. (b) \tRadical radiotherapy patients 9.\tMen receiving neo-adjuvant and/or adjuvant hormone therapy (LHRH agonists, LHRH antagonists, bicalutamide monotherapy) are eligible provided the planned duration of adjuvant therapy is a maximum of three years.This treatment may be ongoing at the time of registration in Add-Aspirin. 10.\tTiming of registration and starting run-in treatment in terms of the treatment pathway should be as described in section 4.2. (c) Salvage radiotherapy patients (following rise in PSA after previous radical prostatectomy) 11.\tMen treated with salvage radiotherapy following a rise in PSA are eligible. Timing of registration and starting run-in treatment in terms of the treatment pathway should be as described in section 4.2. 12.\tMen receiving neo-adjuvant and/or adjuvant hormone therapy (LHRH agonists, LHRH antagonists, bicalutamide monotherapy) are eligible provided the planned duration of adjuvant therapy is a maximum of three years. This treatment may be ongoing at the time of registration in Add-Aspirin."}

Exclusion criteria

• {"criterion_text":"- Breast cohort: 1.\tMetastatic or bilateral breast cancer.\t 2.\tCurrent or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication (see appendix I for list of medications not permitted in the trial). •\tRegular aspirin use is defined as taking aspirin more than twice in any given week for more than 4 consecutive weeks •\tPrevious regular use of aspirin ≥5 years ago is acceptable. Any previous regular aspirin use within the last 5 years should be discussed with the MRC CTU at UCL who will advise on eligibility on a case-by-case basis •\tCurrent NSAID use is defined as taking any NSAID for more than a week in the preceding month •\tIf investigators feel that these definitions may unfairly exclude a participant, this can be discussed with the MRC CTU at UCL and a case by case decision will be made 3.\tA past history of adverse reaction or hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma, that is exacerbated by use of NSAIDs. 4.\tCurrent use of anti-coagulants. 5.\tCurrent or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term therapy. 6.\tActive or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of the bleeding has been surgically removed. 7.\tActive or previous history of inflammatory bowel disease. 8.\tHistory of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2. 9.\tPrevious invasive or non-invasive malignancy except: a.\tDCIS where treatment consisted of resection alone. b.\tCervical carcinoma in situ where treatment consisted of resection alone. c.\tBasal cell carcinoma where treatment consisted of resection alone or radiotherapy. d.\tSuperficial bladder carcinoma where treatment consisted of resection alone or with a single installation of intravesical chemotherapy or with BCG treatment. e.\tOther cancers where the patient has been disease-free for ≥15 years. f.\tOther cancers with very low potential for recurrence can be discussed with MRC CTU at UCL where eligibility will be considered on an individual basis. 10.\tAny other condition (physical or psychological) which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, and patients with a high risk of mortality from another cause within the trial treatment period. 11.\tKnown glucose-6-phosphate dehydrogenase (G6PD) deficiency. 12.\tKnown lactose intolerance. 13.\tLFTs greater than 1.5x the upper limit of normal (with no evidence of residual or metastatic disease) unless the participant has been discussed with the MRC CTU at UCL and the Trial Management Group (TMG) agrees that they are suitable for the trial. This will be decided on a case-by-case basis. Please refer to http://www.addaspirintrial.org/information-for-centres/faqs/ for guidance. 14.\tAnticipated difficulties in complying with trial treatment or follow-up schedules. 15.\t<16years old in the UK and Republic of Ireland or <18 years old in India. 16.\tParticipants in other treatment trials where this has not been agreed in advance by both trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. For all other trials, this should be discussed with the Trial Managers at the MRC CTU at UCL in the first instance. 17.\tPregnant or breast feeding, or intending to become pregnant or breast feed during the trial treatment period. Participants should agree to inform the trial team if they subsequently become pregnant, or plan to become pregnant, whilst they are still receiving treatment in the trial (see section 5.4.4)."}
• {"criterion_text":"- Colorectal cohort: 1.\tProven (or clinically suspected) metastatic disease (patients who have undergone resection of liver metastases (at any time) with clear margins and no residual metastatic disease are eligible). 2.\tCurrent or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication (see appendix I for list of medications not permitted in the trial). •\tRegular aspirin use is defined as taking aspirin more than twice in any given week for more than 4 consecutive weeks •\tPrevious regular use of aspirin ≥5 years ago is acceptable. Any previous regular aspirin use within the last 5 years should be discussed with the MRC CTU at UCL who will advise on eligibility on a case-by-case basis •\tCurrent NSAID use is defined as taking any NSAID for more than a week in the preceding month •\tIf investigators feel that these definitions may unfairly exclude a participant, this can be discussed with the MRC CTU at UCL and a case by case decision will be made 3.\tA past history of adverse reaction/hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma that is exacerbated by use of NSAIDs. 4.\tCurrent use of anti-coagulants. 5.\tCurrent or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term therapy. 6.\tActive or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of the bleeding has been surgically removed. 7.\tActive or previous history of inflammatory bowel disease. 8.\tHistory of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2. 9.\tPrevious invasive or non-invasive malignancy except: a.\tDCIS where treatment consisted of resection alone. b.\tCervical carcinoma in situ where treatment consisted of resection alone. c.\tBasal cell carcinoma where treatment consisted of resection alone or radiotherapy. d.\tSuperficial bladder carcinoma where treatment consisted of resection alone or with a single installation of intravesical chemotherapy or with BCG treatment. e.\tOther cancers where the patient has been disease-free for ≥15 years. f.\tOther cancers with very low potential for recurrence can be discussed with MRC CTU at UCL where eligibility will be considered on an individual basis. 10.\tAny other condition (physical or psychological) which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, and patients with a high risk of mortality from another cause within the trial treatment period. 11.\tKnown G6PD deficiency. 12.\tKnown lactose intolerance. 13.\tLFTs greater than 1.5x the upper limit of normal (with no evidence of residual or metastatic disease) unless the participant has been discussed with the MRC CTU at UCL and the TMG agrees that they are suitable for the trial. This will be decided on a case-by-case basis. Please refer to http://www.addaspirintrial.org/information-for-centres/faqs/ for guidance. 14.\tAnticipated difficulties in complying with trial treatment or follow-up schedules. 15.\t<16 years old in the UK and Republic of Ireland or <18 years old in India. 16.\tParticipants in other treatment trials where this has not been agreed in advance by both trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. For all other trials, this should be discussed with the Trial Managers at the MRC CTU at UCL in the first instance. 17.\tPregnant or breast feeding, or intending to become pregnant or breast feed during the trial treatment period. Participants should agree to inform the trial team if they subsequently become pregnant, or plan to become pregnant, whilst they are still receiving treatment in the trial (see section 5.4.4)."}
• {"criterion_text":"- Gastro-oesophageal cohort: 1.\tProven (or clinically suspected) residual or metastatic disease. 2.\tPatients with stage 1a oesophageal, gastric or gastro-oesophageal junction cancer are not eligible 3.\tCurrent or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication (see appendix I for list of medications not permitted in the trial). •\tRegular aspirin use is defined as taking aspirin more than twice in any given week for more than 4 consecutive weeks •\tPrevious regular use of aspirin ≥5 years ago is acceptable. Any previous regular aspirin use within the last 5 years should be discussed with the MRC CTU at UCL who will advise on eligibility on a case-by-case basis •\tCurrent NSAID use is defined as taking any NSAID for more than a week in the preceding month •\tIf investigators feel that these definitions may unfairly exclude a participant, this can be discussed with the MRC CTU at UCL and a case by case decision will be made 4.\tA past history of adverse reaction/hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma that is exacerbated by use of NSAIDs. 5.\tCurrent use of anti-coagulants. 6.\tCurrent or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term therapy. 7.\tActive or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of the bleeding has been surgically removed. 8.\tActive or previous history of inflammatory bowel disease. 9.\tHistory of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2. 10.\tPrevious invasive or non-invasive malignancy except: a.\tDCIS where treatment consisted of resection alone. b.\tCervical carcinoma in situ where treatment consisted of resection alone. c.\tBasal cell carcinoma where treatment consisted of resection alone or radiotherapy. d.\tSuperficial bladder carcinoma where treatment consisted of resection alone or with a single installation of intravesical chemotherapy or with BCG treatment. e.\tOther cancers where the patient has been disease-free for ≥15 years. f.\tOther cancers with very low potential for recurrence can be discussed with MRC CTU at UCL where eligibility will be considered on an individual basis. 11.\tAny other condition (physical or psychological) which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, and patients with a high risk of mortality from another cause within the trial treatment period. 12.\tKnown G6PD deficiency. 13.\tKnown lactose intolerance. 14.\tLFTs greater than 1.5x the upper limit of normal (with no evidence of residual or metastatic disease) unless the participant has been discussed with the MRC CTU at UCL and the TMG agrees that they are suitable for the trial. This will be decided on a case-by-case basis. Please refer to http://www.addaspirintrial.org/information-for-centres/faqs/ for guidance. 15.\tAnticipated difficulties in complying with trial treatment or follow-up schedules. 16.\t<16years old in the UK and Republic of Ireland or <18 years old in India. 17.\tParticipants in other treatment trials where this has not been agreed in advance by both trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. For all other trials, this should be discussed with the Trial Managers at the MRC CTU at UCL. 18.\tPregnant or breast feeding, or intending to become pregnant or breast feed during the trial treatment period. Participants should agree to inform the trial team if they subsequently become pregnant, or plan to become pregnant, whilst they are still receiving treatment in the trial (see section 5.4.4)."}
• {"criterion_text":"- Prostate cohort: 1.\tBiopsy proven or radiologically suspected nodal involvement or distant metastases from prostate cancer. a.\tT4 patients are ineligible. 2.\tAdjuvant hormone therapy planned for >3years. 3.\tBilateral orchidectomy. 4.\tCurrent or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication (see appendix I for list of medications not permitted in the trial). •\tRegular aspirin use is defined as taking aspirin more than twice in any given week for more than 4 consecutive weeks •\tPrevious regular use of aspirin ≥5 years ago is acceptable. Any previous regular aspirin use within the last 5 years should be discussed with the MRC CTU at UCL who will advise on eligibility on a case-by-case basis •\tCurrent NSAID use is defined as taking any NSAID for more than a week in the preceding month. •\tIf investigators feel that these definitions may unfairly exclude a participant, this can be discussed with the MRC CTU at UCL and a case by case decision will be made 5.\tA past history of adverse reaction/hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma that is exacerbated by use of NSAIDs. 6.\tCurrent use of anti-coagulants. 7.\tCurrent or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term therapy. 8.\tActive or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of the bleeding has been surgically removed. 9.\tActive or previous history of inflammatory bowel disease. 10.\tHistory of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2. 11.\tPrevious invasive or non-invasive malignancy except: a.\tProstate cancer initially treated with prostatectomy and now being treated with salvage radiotherapy following a rise in PSA. b.\tBasal cell carcinoma where treatment consisted of resection alone or radiotherapy. c.\tLow grade superficial bladder carcinoma where treatment consisted of endoscopic resection alone or with a single installation of intravesical chemotherapy or with BCG treatment. d.\tOther cancers where the patient has been disease-free for ≥15 years. e.\tOther cancers with very low potential for recurrence can be discussed with MRC CTU at UCL where eligibility will be considered on an individual basis. 12.\tAny other condition (physical or psychological) which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, and patients with a high risk of mortality from another cause within the trial treatment period. 13.\tKnown G6PD deficiency. 14.\tKnown lactose intolerance. 15.\tLFTs greater than 1.5x the upper limit of normal (with no evidence of residual or metastatic disease) unless the participant has been discussed with the MRC CTU at UCL and the TMG agrees that they are suitable for the trial. This will be decided on a case-by-case basis. Please refer to http://www.addaspirintrial.org/information-for-centres/faqs/ for guidance. 16.\tAnticipated difficulties in complying with trial treatment or follow-up schedules. 17.\t<16years old in the UK and Republic of Ireland or <18 years old in India. 18.\tParticipants in other treatment trials where this has not been agreed in advance by both trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. For all other trials, this should be discussed with the Trial Managers at the MRC CTU at UCL or TMC (India) prior to registration."}

Primary endpoints

• {"endpoint_text":"- All participants: Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Breast cancer participants: Invasive disease-free survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Colorectal cancer: Disease-free survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Gastro-oesophageal cancer: Disease-free survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Prostate cancer: Biochemical recurrence-free survival","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Adherence","definition_or_measurement_approach":""}
• {"endpoint_text":"- Toxicity","definition_or_measurement_approach":""}
• {"endpoint_text":"- Serious haemorrhage","definition_or_measurement_approach":""}
• {"endpoint_text":"- Serious vascular events","definition_or_measurement_approach":""}
• {"endpoint_text":"- Thrombotic events","definition_or_measurement_approach":""}
• {"endpoint_text":"- Diabetes and associated complications","definition_or_measurement_approach":""}
• {"endpoint_text":"- Second malignancies","definition_or_measurement_approach":""}
• {"endpoint_text":"- Age-related macular degeneration","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cognitive assessment","definition_or_measurement_approach":""}
• {"endpoint_text":"- Dementia","definition_or_measurement_approach":""}
• {"endpoint_text":"- Functional capacity","definition_or_measurement_approach":""}
• {"endpoint_text":"- Exercise levels","definition_or_measurement_approach":""}
• {"endpoint_text":"- Breast cancer-specific survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Bone metastases-free survival (breast cancer)","definition_or_measurement_approach":""}
• {"endpoint_text":"- IDFS-DCIS (invasive disease-free survival ductal carcinoma in-situ) (breast cancer)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Colorectal cancer-specific survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Prostate cancer-specific survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to initiation of salvage treatment (prostate cancer)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Bone metastases-free survival (prostate cancer)","definition_or_measurement_approach":""}

Ireland

Earliest CTIS Part Ii Submission Date

30-01-2024

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

511

Number Of Sites

10

Number Of Participants

204

Primary sponsor

Full Name

University College London

Organisation Type

Educational Institution

Country Of Registered Address

United Kingdom