UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009365 |
|---|---|
| Receipt number | R000011005 |
| Scientific Title | Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis |
| Date of disclosure of the study information | 2012/11/24 |
| Last modified on | 2023/05/28 09:42:14 |
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Basic information
Public title
Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis
Acronym
Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with FAP
Scientific Title
Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis
Scientific Title:Acronym
Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with FAP
Region
| Japan |
Condition
Condition
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
Graduate School of Medical Science, Kyoto
Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-5444
cancer@gol.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Graduate School of Medical Science, Kyoto
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-5444
Homepage URL
cancer@gol.com
Sponsor or person
Institute
AMED
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Science, Kyoto
Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Address
Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN
Tel
075-251-5111
soumu@koto.kpu-m.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
宝塚市立病院（兵庫県）、癌研有明病院（東京都）、埼玉医科大学（埼玉県）、尾田胃腸科（熊本県）、昭和大学横浜市北部病院（神奈川県）、東京都立駒込病院（東京都）、木村病院（兵庫県）、札幌医科大学（北海道）、佐野病院（兵庫県）、名古屋市立大学（愛知県）、愛知医科大学（愛知県）、徳島大学（徳島県）、チクバ外科（岡山県）、愛知県がんセンター（愛知県）、岩国医療センター（山口県）、広島大学（広島県）、兵庫医科大学（兵庫県）、福岡山王病院（福岡県）、国立がん研究センター中央病院（東京都）、九州大学（福岡県）、丸岡正典消化器内科（大阪府）、東京大学（東京都）、石川消化器内科（大阪府）、胃腸病院（大阪府）、近畿大学（大阪府）、国立がん研究センター東病院（東京都）、守口敬任会病院（大阪府）、大阪府立成人病センター（大阪府）、石川県立中央病院（石川県）、東邦大学大橋病院（東京都）、四国がんセンター（愛媛県）、静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 24 | 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
222
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Papers being submitted for publication
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
Main results already published
Date of protocol fixation
| 2012 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011005
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/12/28 | J-FAPP III：データ（固定用）.xlsx |
