Single-arm intervention clinical trial with low-dose aspirin in patients with familial adenomatous polyposis (J-FAPP Study V)

未提供0 个研究点目标入组 200 人开始时间: 2022年7月23日最近更新: 2025年4月3日

适应症

试验速览

暂无简介。

•Patients with familial adenomatous polyposis.
•No colectomy (Except for an appendectomy).
•Those who have had all colorectal polyps of 5.0 mm or more removed endoscopically and no remaining polyps of 5.0 mm or more.
•16 to 70 years old (regardless of sex)
•The patient has given written consent prior to enrollment in this study.

•Those who fall under any of the following are not included in this study.
•Those who are currently taking antithrombotic agents and anticoagulants (trade names: biaspyrin, bufferin, panaldine, warfarin, persantin, etc.).
•A history of stroke (transient ischemic attack: including TIA).
•Patients with a history of treatment for gastric ulcer and duodenal ulcer . (Those who have confirmed S2 healing of ulcers after successful eradication of Helicobacter pylori, can participate)
•Easy occurrence of inflammatory bowel disease (ulcerative colitis, Crohn's disease), hemorrhagic diverticulitis, severe hemorrhagic gastritis, etc.
•Those with bleeding tendency, platelet count 100,000 / ul or less, white blood cell 3,000 / ul or less.
•A person with a malignant tumor that is progressive or requires treatment at the time of entry. (except undergone curative resection).
•Those who are undergoing anti-cancer drug treatment or radiation therapy.
•Those who have a history of allergies to aspirin or the preparation of salicylic acid.
•Those who are pregnant and plan to become pregnant during the study period.
•Those who take NSAIDs at least 3 times a week for pain relief.
•Those who took sulindac for the purpose of reducing polyps, but not have passed 6 months after stopping it.
•Smokers (including heated cigarettes)

Cumulative rate of polyps of 5.0 mm or more over 2 years (8th, 16th, 24th month).

Cumulative incidence of high-grade dysplasia, cancer, and polyps(2 years)
Number of polyps with a cumulative size of 5.0 mm or more and number of polyps removed(2 years)
Difference in the incidence of colorectal polyps of >= 5.0 mm(Months 8 and 24)
Increase or decrease in tumors throughout the large intestine
Increase or decrease in upper gastrointestinal tract tumors
Presence or absence of adverse events
Increase or decrease in adenomas < 5.0 mm
Proportion of patients with severe disease such as cancer or conversion to the dense form
Presence or absence of colorectal surgery during the intervention period(intervention period)
Number of cases of cancer in other organs during the observation period(observation period)
Intervention-Related pathological tissue changes

发起方

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