Assessment of aspirin for the prevention of colorectal cancer

Phase 1

Conditions: Colorectal cancer with a recent confirmed diagnosis (less than 48h)
MedDRA version: 20.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-002101-65-ES

Lead Sponsor: Ángel Lanas Arbeloa-Instituto de Investigación Sanitaria Aragón

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

- Age from 18 to 80 years old
- Recent diagnosis (less than 48h) of colorectal cancer by endoscopy and confirmed by anatomopathological study
- normal hematologic, biochemical, and coagulation values
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Allergy to AAS or to any other NSAID.
- Rectal cancer requiring neoadjuvant treatment wthin the two weeks following the beginning of ASA treatment.
- Previous use of AAS, NSAIDs, antiplatelet agents, corticosteroids or misoprostol within the 15 days prior to diagnosis and/or anticipation of need for treatment with any of these drugs during the study period.
History of peptic ulcer disease or active peptic ulcer or any other GI disease that may be considered a contraindication to the use of ASA, without the concomitant use of proton pump inhibitors.
- Diagnosis of bleeding disorders.
- Diagnosis of cancer (excluding non-melanoma skin cancer) during the previous 3 years.
- Conditions supposing serious comorbidity, excluding diabetes, and including respiratory, cardiac, hepatic and renal diseases.
- Active smoking.
- Pregnancy or breastfeeding.
- History of drug or alcohol abuse.