UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000697
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email cancer@gol.com

Sponsor
Institute Basic and clinical researches on the development of chemopreventive drugs
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.