Acetylsalicylic acid for Colorectal cancer

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years and < 80 years.\n- Recent diagnosis (colon or rectal cancer, established by endoscopy and subsequently confirmed by anatomo-pathological study).\n- Coagulation study within the normal range and usual biochemical parameters without clinically significant deviations that, in the opinion of the investigator, could interfere with the study procedures.\n- In the obese group, patients with BMI ≥ 30 will be selected. In the non-obese group, patients with BMI ≤ 25 will be selected."}

Exclusion criteria

• {"criterion_text":"- Allergy to ASA or other salicylates, non-steroidal anti-inflammatory drugs or tartrazine (cross-reaction) or any of the excipients. Allergy to other salicylates, non-steroidal anti-inflammatory drugs or tartrazine (cross-reaction) or any of the excipients.\n- History of drug use or alcohol abuse.\n- Diseases with coagulation disorders, mainly hemophilia or hypoprothrombinemia.\n- Treatment with methotrexate at doses of 15 mg/week or higher\n- Patients with nasal polyps associated with asthma that are induced or exacerbated by acetylsalicylic acid.\n- Rectal cancer requiring neoadjuvant treatment within three weeks of starting treatment with ASA.\n- Previous use of ASA, NSAIDs, antiplatelet agents, corticosteroids or misoprostol in the 15 days prior to diagnosis and/or anticipated need for treatment with any of these drugs during the study period.\n- History of peptic ulcer or active peptic ulcer or any other GI disease that may be considered a contraindication to the use of ASA, without concomitant use of proton pump inhibitors.\n- Diagnosis of bleeding disorders or gastric perforation after treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.\n- Diagnosis of cancer (excluding non-melanoma skin cancer) in the previous 3 years\n- Conditions involving serious comorbidity, excluding diabetes and including respiratory, cardiac, liver and kidney diseases.\n- Active smoking\n- Pregnancy or breastfeeding status."}

Primary endpoints

• {"endpoint_text":"- Effect of two courses (1 week/course) of different doses of ASA on COX-1 and COX-2 in patients diagnosed with colorectal cancer","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

23-10-2024

Latest Decision Or Authorization Date

05-11-2024

Processing Time Days

13

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Fundacion Instituto De Investigacion Sanitaria Aragon

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain