UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000697 |
|---|---|
| Receipt number | R000000834 |
| Scientific Title | Japan colorectal tumor prevention study: randomized controlled trial by low-dose aspirin |
| Date of disclosure of the study information | 2007/05/02 |
| Last modified on | 2019/11/10 14:42:12 |
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Basic information
Public title
Japan colorectal tumor prevention study:
randomized controlled trial by low-dose aspirin
Acronym
Japan colorectal tumor prevention study:
randomized controlled trial by low-dose aspirin (J-CAPP Study)
Scientific Title
Japan colorectal tumor prevention study:
randomized controlled trial by low-dose aspirin
Scientific Title:Acronym
Japan colorectal tumor prevention study:
randomized controlled trial by low-dose aspirin (J-CAPP Study)
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the colorectal cancer preventive effect of aspirin enteric-coated tablet (100 mg, one tablet daily) in oriental people in a double-blind, randomized study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Only the occurrence of a colorectal tumor (adenoma or cancer) is selected as the primary endpoint.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Aspirin (100 mg/day) enteric-coated tablet
Interventions/Control_2
Placebo tablet / day
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
| 70 | 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 (at any time)
# Patients with known history of all endoscopic treatments (including histological diagnosis) of colorectal tumors
# Patients who have undergone total colonoscopy at least twice
# Patients with clean colon as confirmed by total colonoscopy within 3 months before the study
Key exclusion criteria
# Patients with a medical history of submucosal or deeper colorectal cancer.
# Patients currently taking antithrombotics such as Bayaspirin, Bufferin, Panaldine, Warfarin and Persantin.
# Patients who have undergone colorectal resection (those who have undergone appendectomy are allowed to participate in the study).
# Patients with familial colorectal adenoma.
# 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 bleeding tendency, a platelet count of 150,000, or with abnormal PT
# Patients with any existing cancer at the time of participation in the study.
# Patients with known allergy to aspirin.
# Patients currently taking anticancer drugs.
# Women who are or may be pregnant during the study period.
# Patients currently taking NSAIDs at least 3 times weekly, for example, as a analgesic.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Sadao |
| Middle name | |
| Last name | Suzuki |
Organization
Nagoya City University Medical School
Division name
Department of Health Promotion and Preventive Medicine
Zip code
467-8602
Address
Mizuho-ku, Nagoya 467-8601
TEL
052-853-8174
ssuzuki@med.nagoya-cu.ac.jp
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
3-1-2F Kyomachibori Nishi-ku 2-chome Osaka 550-0003, Japan
TEL
06-6445-5585
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Basic and clinical researches on the development of chemopreventive drugs
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Third Research Project on General Strategy Against Cancer
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
Nagoya City University Medical School
Address
Mizuho-ku, Nagoya 467-8601
Tel
052-853-8174
tokudome@med.nagoya-cu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24488498
Number of participants that the trial has enrolled
Results
Gut. 2014 Jan 31. doi: 10.1136/gutjnl-2013-305827. [Epub ahead of print]
The preventive effects of low-dose enteric-coated aspirin tablets on the development of colorectal tumours in Asian patients: a randomised trial.
Ishikawa H1, Mutoh M, Suzuki S, Tokudome S, Saida Y, Abe T, Okamura S, Tajika M, Joh T, Tanaka S, Kudo SE, Matsuda T, Iimuro M, Yukawa T, Takayama T, Sato Y, Lee K, Kitamura S, Mizuno M, Sano Y, Gondo N, Sugimoto K, Kusunoki M, Goto C, Matsuura N, Sakai T, Wakabayashi K.
OBJECTIVE:
To evaluate the influence of low-dose, enteric-coated aspirin tablets (100 mg/day for 2 years) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy.
DESIGN:
A double-blinded, randomised, placebo-controlled multicentre clinical trial was conducted.
PARTICIPANTS:
311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study (152 patients in the aspirin group and 159 patients in the placebo group). Enrolment began at the hospitals (n=19) in 2007 and was completed in 2009.
RESULTS:
The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 (95% CI 0.36 to 0.98) compared with the subjects in the placebo group. Subgroup analysis revealed that subjects who were non-smokers, defined as those who had smoked in the past or who had never smoked, had a marked reduction in the number of recurrent tumours in the aspirin-treated group. The adjusted OR for aspirin treatment in non-smokers was 0.37 (CI 0.21 to 0.68, p<0.05). Interestingly, the use of aspirin in smokers resulted in an increased risk, with an OR of 3.44. In addition, no severe adverse effects were observed in either group.
CONCLUSIONS:
Low-dose, enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population. The results are consistent with those obtained from other randomised controlled trials in Western countries.
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
Main results already published
Date of protocol fixation
| 2006 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2006 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 05 | Month | 01 | Day |
Last modified on
| 2019 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000834
