UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018734 |
|---|---|
| Receipt number | R000021671 |
| Scientific Title | Japan colorectal tumor prevention study: clinical trial by low-dose aspirin |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2021/09/08 09:37:10 |
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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
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
cancer@gol.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021671
