GALLIUM (68GA) CHLORIDE for Venous thromboembolism | Occult malignancy (cancer)

Inclusion criteria

• {"criterion_text":"- Patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) ≤ 4 weeks as detailed below will be eligible to participate into the study."}
• {"criterion_text":"- No recent paralysis, paresis, or prolonged immobilization> 3 days for acute medical condition or plaster cast of the lower limbs in the last 3 months."}
• {"criterion_text":"- No major surgery (within the past 3 months) requiring general or regional anaesthesia"}
• {"criterion_text":"- No biological or clinical thrombophilia"}
• {"criterion_text":"- No active malignancy (known malignancy, progressive and/or treated during the last 5 years) except for adequately treated basal or squamous cell carcinoma. Patients whose state of health suggests the presence of cancer at the time of diagnosis of VTE cannot be included in the protocol."}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph"}
• {"criterion_text":"- Unavailable to follow-up"}
• {"criterion_text":"- VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)"}
• {"criterion_text":"- VTE provoked by a major inherited or acquired risk factor"}
• {"criterion_text":"- Refusal or inability to provide informed consent"}
• {"criterion_text":"- Life expectancy <12 months"}
• {"criterion_text":"- Ongoing pregnancy"}
• {"criterion_text":"- Vulnerable individuals (Persons deprived of their liberty by judicial or administrative decision; Persons under psychiatric care under duress; Persons admitted to a health or social institution for purposes other than research; Persons of full age subject to a legal protection measure; persons under protective custody)"}

Primary endpoints

• {"endpoint_text":"- Occult cancer “missed” by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening.","definition_or_measurement_approach":"Defined as proven cancer diagnosed either by biopsy or by adjudication committee in absence of biopsy-proven cancer, occurring from completion of screening to end of 1-year follow-up and not detected at time of screening."}

Secondary endpoints

• {"endpoint_text":"- 1) New cancer diagnosis after completion of the initial allocated screening strategy.","definition_or_measurement_approach":"Diagnosis of new cancer after completion of the initially allocated screening strategy."}
• {"endpoint_text":"- 2) Early-stage (T1-2N0M0 as per the World Health Organization TNM classification system) and advanced-stage tumors at initial screening and during follow-up.","definition_or_measurement_approach":"Tumor stage classified using WHO TNM (early-stage defined as T1-2N0M0)."}
• {"endpoint_text":"- 3) Cancer-related mortality during a 5-year follow-up period.","definition_or_measurement_approach":"Cancer-related deaths assessed over a 5-year follow-up period."}
• {"endpoint_text":"- 4) Diagnosis of cancer and costs from the viewpoint of the healthcare system over a one-year period in order to estimate the additional cost per additional cancer detected and the incremental cost utility ratio","definition_or_measurement_approach":"Economic evaluation over one year to estimate additional cost per additional cancer detected and incremental cost-utility ratio from healthcare system perspective."}
• {"endpoint_text":"- 5) Additional tests following each strategy and during follow-up.","definition_or_measurement_approach":"Proportion/frequency of additional diagnostic tests performed after each screening strategy at baseline and during follow-up."}
• {"endpoint_text":"- 6) The data of this study will be used to develop a decision aid to assist future patients in the decision of cancer screening","definition_or_measurement_approach":"Study data to inform development of a patient decision aid (methodological details not specified)."}

France

Earliest CTIS Part Ii Submission Date

31-05-2024

Latest Decision Or Authorization Date

18-06-2024

Processing Time Days

18

Number Of Sites

10

Number Of Participants

638

Primary sponsor

Full Name

Centre Hospitalier Regional Et Universitaire De Brest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France