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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018742
Receipt No. R000021685
Scientific Title Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis -2
Date of disclosure of the study information 2015/08/21
Last modified on 2016/08/20

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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
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, Chuo-ku, Osaka 541-0042, Japan
TEL 06-6202-5444
Email cancer@gol.com

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, 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
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 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)
大阪府立成人病センター(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)
群馬中央総合病院(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)
東芝病院(東京都)
守口敬任会病院(大阪府)
産業医科大学病院(福岡県)
宝塚市立病院(兵庫県)

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
Anticipated trial start date
2015 Year 09 Month 14 Day
Last follow-up date
2022 Year 06 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
2016 Year 08 Month 20 Day


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

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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