UMIN-CTR Clinical Trial

Basic information
Public title	Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis -2
Acronym	Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with FAP -2 (J-FAPP Study 3-2)
Scientific Title	Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis -2
Scientific Title:Acronym	Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with FAP -2 (J-FAPP Study 3-2)
Region	Japan

Condition
Condition	Patients with familial adenomatous polyposis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness and safety of thorough endoscopic polypectomy in patients with FAP.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Whether or not a patient needs surgery on the large intestine during the intervention period. It includes not only the development of a polyp that cannot be removed endoscopically or that of large intestinal cancer, but also cases where a patient wishes to undergo resection of the large intestine because of discomfort of endoscopic examination, and cases where emergency surgery is performed because of perforation occurred during endoscopic treatment.
Key secondary outcomes	Presence or absence of the development of adverse events (perforation, hemorrhage, death from large intestinal cancer, and death from other causes), colorectal cancer, intramucosal carcinoma, or a tumor that is difficult to treat endoscopically.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Colonic polyps will be thoroughly removed by periodic colonoscopy.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have (or had) 100 or more adenomas in the large intestine and who refused to undergo surgery despite of being advised to do so, and who are 16 years or older (parental consent is required in patients younger than 20 years). Patients who have (or had) 100 or more adenomas in the large intestine and who had part of the large intestine resected by surgery but still have 10 cm or more of the large intestine, and who are 16 years or older (parental consent is required in patients younger than 20 years).
Key exclusion criteria	Patients who are considered by their attending physicians to be ineligible to participate in the study because they have a serious disease in other organs, or because they cannot discontinue antiplatelet drugs, or for other reasons. Patients who are receiving anticancer drugs. Patients with dense FAP in at least one-third of the large intestine. Patients in whom strict follow-up is difficult.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Ishikawa
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular-Targeting Prevention
Zip code	541-0042
Address	3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL	06-6202-5444
Email	cancer@gol.com

Public contact
Name of contact person	1st name Hideki Middle name Last name Ishikawa
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular-Targeting Prevention
Zip code	541-0042
Address	3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL	06-6202-5444
Homepage URL
Email	cancer@gol.com

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto Prefectural University of Medicine
Address	602-8566 Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN
Tel	private
Email	private

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	石川消化器内科（大阪府） 札幌医科大学附属病院（北海道） 愛知県がんセンター中央病院（愛知県） 国立がん研究センター中央病院（東京都） 兵庫医科大学病院（兵庫県） 徳島大学病院（徳島県） 広島大学病院（広島県） 石川県立中央病院（石川県） 大阪国際がんセンター（大阪府） 佐野病院（兵庫県） 栃木県立がんセンター（栃木県） 岩国医療センター（山口県） 四国がんセンター（愛媛県） 群馬中央病院（群馬県） がん研有明病院（東京都） 国立がん研究センター東病院（千葉県） 近畿大学医学部附属病院（大阪府） 東邦大学医療センター大橋病院（東京都） 京都大学医学部附属病院（京都府） 埼玉医科大学総合医療センター（埼玉県） 守口敬仁会病院（大阪府） 産業医科大学病院（福岡県） 帯広厚生病院（北海道） 九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 21 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	Enrolling by invitation
Date of protocol fixation	2015 Year 08 Month 20 Day
Date of IRB	2015 Year 09 Month 03 Day
Anticipated trial start date	2015 Year 09 Month 14 Day
Last follow-up date	2026 Year 09 Month 30 Day
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 20 Day
Last modified on	2021 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021685