UMIN-CTR Clinical Trial

Basic information
Public title	Japan colorectal tumor prevention study: clinical trial by low-dose aspirin
Acronym	Japan colorectal tumor prevention study: clinical trial by low-dose aspirin (J-CAPP Study 2)
Scientific Title	Japan colorectal tumor prevention study: clinical trial by low-dose aspirin
Scientific Title:Acronym	Japan colorectal tumor prevention study: clinical trial by low-dose aspirin (J-CAPP Study 2)
Region	Japan

Condition
Condition	Patients with colorectal tumor (adenoma, carcinoma in situ)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	he objective of this study is to evaluate the colorectal cancer preventive effect of aspirin enteric-coated tablet (100 mg, one tablet daily) in a single arm study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	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.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	aspirin enteric-coated tablet (100 mg, one tablet daily) for four years
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key 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.
Key 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. # Patients currently taking anticancer drugs. # Patients currently taking NSAIDs at least 3 times weekly, for example, as a analgesic.
Target sample size	7000

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Ishikawa
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular-Targeting Cancer Prevention
Zip code	541-0042
Address	3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL	06-6202-5444
Email	cancer@gol.com

Public contact
Name of contact person	1st name Hideki Middle name Last name Ishikawa
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular-Targeting Cancer Prevention
Zip code	541-0042
Address	3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL	06-6202-5444
Homepage URL
Email	cancer@gol.com

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Not for public release
Address	Not for public release
Tel	Not for public release
Email	Not for public release

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	NTT東日本札幌病院（北海道）、斗南病院（北海道）、秋田赤十字病院（秋田県）、国立がん研究センター中央病院（東京都）、東京慈恵会医科大学（東京都）、国立がん研究センター東病院（千葉県）、東邦鎌谷病院（千葉県）愛知がんセンター（愛知県）、静岡県立静岡がんセンター（静岡県）、石川県立中央病院（石川県）、金沢医科大学（石川県）、京都桂病院（京都府）、石川消化器内科（大阪府）、近畿大学（大阪府）、北摂総合病院（大阪府）、大阪国際がんセンター（大阪府）、宝塚市立病院（兵庫県）、佐野病院（兵庫県）、広島大学（広島県）、広島市立安佐市民病院（広島県）、四国がんセンター（愛媛県）、尾田胃腸内科（熊本県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 07 Month 22 Day
Date of IRB	2015 Year 07 Month 22 Day
Anticipated trial start date	2015 Year 09 Month 07 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry	2024 Year 08 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 08 Month 20 Day
Last modified on	2021 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021671