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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018817
Receipt No. 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

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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
Email 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
Email cancer@gol.com

Sponsor
Institute Management Committee
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021537

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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