UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012022 |
|---|---|
| Receipt number | R000007094 |
| Scientific Title | Effect of Broccoli Sprouts Intervention on Chemoprevention against Colon Cancer |
| Date of disclosure of the study information | 2013/10/11 |
| Last modified on | 2018/05/12 21:23:32 |
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Basic information
Public title
Effect of Broccoli Sprouts Intervention on Chemoprevention against Colon Cancer
Acronym
BS-CCPT (Broccoli Sprouts-Colon Cancer Prevention Trial)
Scientific Title
Effect of Broccoli Sprouts Intervention on Chemoprevention against Colon Cancer
Scientific Title:Acronym
BS-CCPT (Broccoli Sprouts-Colon Cancer Prevention Trial)
Region
| Japan |
Condition
Condition
Colonic Adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estabish effective method for chemoprevention against colon cancer by dietary intake of broccoli sprouts
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Number of aberrant crypt foci(ACF) in rectal mucosa
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 6 months
Total Amount:4,500 gram(=50 gram x 90)
Single dose: 50 gram/time
Frequency:once per 2 days
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Endoscopically diagnosed colonic adenoma
Key exclusion criteria
Patients with active or inactive IBD
NSAIDs User
Patients taking Warfarin
Allergy to broccoli sprouts
Paitients judged as inappropriate fo this study for some reasons by medical doctors
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinori Yanaka, MD and PhD |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Gastroenterology
Zip code
Address
1-1-1Tennodai, Tsukuba-shi, Ibaraki-ken, 305-8575, Japan
TEL
0294-23-1111
ynk-aki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Suzuki, MD and PhD |
Organization
Univeristy of Tsukuba
Division name
Gastroenterology
Zip code
Address
1-1-1Tennodai, Tsukuba-shi, Ibaraki-ken, 305-8575, Japan
TEL
029-853-3218
Homepage URL
hideoszk@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba hospital,
Hitachi Medical Education and Research
Center
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba hospital,
Hitachi Medical Education and Research
Center
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
| 2013 | Year | 10 | Month | 11 | 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
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 25 | 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
| 2013 | Year | 10 | Month | 11 | Day |
Last modified on
| 2018 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007094
