Japan colorectal tumor prevention study: clinical trial by low-dose aspirin (J-CAPP Study II)

JRCT ID: jRCTs051180161

Registered date:25/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients with colorectal tumor (adenoma, carcinoma in situ)
• Date of first enrollment: 24/09/2015
• Target sample size: 4500
• Study type: Interventional
• Intervention(s): Medicate

Outcome(s)

• Primary Outcome: The primary endpoint is set as the incidence of newly diagnosed colorectal Index Lesion (adenomas >= 10 mm in diameter, adenomas with high-grade dysplasia, or invasive cancer) during 4 years observation excluding the first-year observation.
• Secondary Outcome: The secondary endpoints included i) the frequency of adverse effects, development of cancers in other organs, the occurrence of newly diagnosed colorectal tumors (adenoma and adenocarcinoma) at the first year colon endoscopy, ii) the number, size and histology (examination of a grade of atypism and existence of a villus-like colon adenoma) of the colorectal tumors that detected at the first and 4th year colon endoscopy, and iii) the occurrence of newly diagnosed colorectal tumors (adenoma and adenocarcinoma) at the 7th year colon endoscopy. Regarding diagnosis of borderline lesion, central review will be considered.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 69age old
• Gender: Both

Include 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.

Exclude 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.
# Patients currently taking anticancer drugs.
# Patients currently taking NSAIDs at least 3 times weekly, for example, as a analgesic.

Related Information

• Primary Sponsor: Ishikawa Hideki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000018734