UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018817 |
|---|---|
| Receipt number | R000021537 |
| Scientific Title | Japan colorectal tumor prevention study: randomized controlled trial of curcumin |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2017/11/27 08:51:16 |
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Basic information
Public title
Japan colorectal tumor prevention study:
randomized controlled trial of curcumin
Acronym
Japan colorectal tumor prevention study:
randomized controlled trial of curcumin
(J-CAP-C)
Scientific Title
Japan colorectal tumor prevention study:
randomized controlled trial of curcumin
Scientific Title:Acronym
Japan colorectal tumor prevention study:
randomized controlled trial of curcumin
(J-CAP-C)
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 curcumin a double-blind randomized study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
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
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
curucmin 360mg/day
Interventions/Control_2
placebo
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
| 30 | years-old | <= |
Age-upper limit
| 75 | 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, Persantin and NOAC.
# 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 any existing cancer at the time of participation in the study.
# Patients with known allergy to curcumin.
# 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.
# Patients with ulcerative colitis or Crohn's disease
# Patients with bleeding tendency or platelet count less than 70,000.
# Patient taking turmeric as a supplement.
# Patient deemed inappropriate by a doctor
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuji Takayama |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of Gastroenterology and Oncology
Zip code
Address
2-50-1 Kuramotocho Tokushima City, Japan
TEL
088-631-3111
takayama@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
Address
3-2-17 2F Imabashi Tyuo-ku Osaka City, Japan
TEL
06-6202-6566
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Management Committee
Institute
Department
Personal name
Funding Source
Organization
THERAVALUES CORPORATION
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2017 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021537
