JPRN-jRCTs051180161
Active, not recruiting
Phase 3
Japan colorectal tumor prevention study: clinical trial by low-dose aspirin(100 mg/day) - Japan colorectal tumor prevention study: clinical trial by low-dose aspirin (J-CAPP Study II)
Ishikawa Hideki0 sites4,500 target enrollmentMarch 25, 2019
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Patients with colorectal tumor (adenoma, carcinoma in situ)
- Sponsor
- Ishikawa Hideki
- Enrollment
- 4500
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Candidate patients have to meet all the following inclusion criteria to participate in the study.
- •\# Patients with at least one colorectal tumor (intramucosal cancer and adenoma) as confirmed by histological diagnosis, all of which have been removed endoscopically including the past.
- •\# Patients with known history of all endoscopic treatments (including histological diagnosis) of colorectal tumors. Patients without histological diagnosis but have histological sections could participate in the trial.
- •\# Patients who have undergone total colonoscopy at least twice.
- •\# Patients with clean colon as confirmed by total colonoscopy within 3 months before the study. All histological diagnosis of the colorectal polyps should be done before the trial start.
Exclusion Criteria
- •\# Patients with a medical history of submucosal (sm) or deeper colorectal cancer.
- •\# Patients with familial adenomatous polyposis or Lynch syndrome.
- •\# Patients currently taking antithrombotics such as Bayaspirin, Panaldine, Warfarin and Persantin etc.
- •\# Patients with known allergy to aspirin.
- •\# Patients who have undergone colorectal resection (those who have undergone appendectomy are allowed to participate in the study).
- •\# Women who are or may be pregnant during the study period.
- •\# Patients with a history of treatment of gastric or duodenal ulcer (those with successful eradication of Helicobacter pylori and ulcer resolution at S2 are allowed to participate in the study)
- •\# Patients with inflammatory bowel disease (ulcerative colitis, Crohn syndrome), bleeding diverticulosis, bleeding gastritis.
- •\# Patients with bleeding tendency, a platelet count of \< 100,000 /mm3, or with abnormal prothrombin time.
- •\# Patients with any existing cancer at the time of participation in the study.
Outcomes
Primary Outcomes
Not specified
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