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Clinical Trials/JPRN-jRCTs051180161
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.

Registry
who.int
Start Date
March 25, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ishikawa Hideki

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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