UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of additional metformin to aspirin for human rectal aberrant crypt foci: double-blinded randomized controlled trial
Acronym	The efficacy of aspirin and metformin for rectal ACF
Scientific Title	The efficacy of additional metformin to aspirin for human rectal aberrant crypt foci: double-blinded randomized controlled trial
Scientific Title:Acronym	The efficacy of aspirin and metformin for rectal ACF
Region	Japan

Condition
Condition	Patients with both colorectal ACF and resectable polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the chemopreventive effect of additional metfromin to aspirin against the rectal ACF
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II,III

Assessment
Primary outcomes	The amount of change rectal ACF in aspirin plus placebo group and aspirin plus metformin group after 8weeks intervention
Key secondary outcomes	The number of rectal ACF before and after intervention in both group Ki67 labeling index of colorectal adnoema/cancer and normal mucosa before and after intervention Safety

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	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	receive 100mg aspirin and placebo for 8 weeks
Interventions/Control_2	receive 100mg aspirin and 250mg metformin for 8 weeks
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients with resectable polyps. 2.Patients with more than 10 rectal ACF 3.Willingness to provide written informed consent
Key exclusion criteria	1.Patients with lesion which preferred early resection. 2.History of regular use (defined as at least once per week) of NSAIDs and/or aspirin. 3.History of regular use of warfarin and/or DOAC. 4.History of diabetes mellitus (defined as more than HbA1c 6.5% or regular use of anti-diabetic drugs) . 5.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure 6.History of familial adenomatous polyposis, hereditary non-polyposis colorectal cancer and inflammatory bowel disease 7.Pregnancy or possibility of pregnancy 8.Contraindication to aspirin or metformin 9.Allergy to aspirin or metformin 10.Patients judged as inappropriate candidates for the trial by the investigators
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Higurashi Middle name Last name Takuma
Organization	Yokohama City University
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
TEL	045-787-2640
Email	takuma_h@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Higurashi Middle name Last name Takuma
Organization	Yokohama City University
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa, Yokohama, Kanagawa
TEL	045-787-2640
Homepage URL
Email	takuma_h@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University Hospital
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	Yokohama City University Hospital IRB
Address	3-9 Fukuura Kanazawa-ku Yokohama City
Tel	045-787-2640
Email	rinri@yokohama-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	横浜市立大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 18 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	2017 Year 07 Month 01 Day
Date of IRB	2016 Year 11 Month 24 Day
Anticipated trial start date	2017 Year 07 Month 18 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 17 Day
Last modified on	2020 Year 01 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032336

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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