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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name