UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056754 |
|---|---|
| Receipt number | R000064859 |
| Scientific Title | Registry and observational study of familial adenomatous polyposis |
| Date of disclosure of the study information | 2025/01/20 |
| Last modified on | 2025/01/19 14:11:54 |
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Basic information
Public title
Registry and observational study of familial adenomatous polyposis
Acronym
J-FAPP Study registry
Scientific Title
Registry and observational study of familial adenomatous polyposis
Scientific Title:Acronym
J-FAPP Study registry
Region
| Japan |
Condition
Condition
Familial adenomatous polyposis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the natural history of familial adenomatous polyposis and the effectiveness of novel treatments such as intensive downstaging polypectomy (IDP) and aspirin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Life and Death
Key secondary outcomes
-Development of colorectal cancer
-Development of non-colorectal cancer
-Performance of colorectomy
-Presence of desmoid
- Colorectal polyp findings
- Concomitant diseases
- Adverse events associated with IDP, such as bleeding (grade, blood transfusion), perforation, emergency surgery, etc.
- Birth status
- Employment status
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 with adenomatous polyposis (those with 100 or more adenomas in the colorectum or those who have had 100 or more adenomas in total) who have visited a participating institution from January 2008 to March 31, 2027, or those with a pathogenic variant in the APC gene in the germline
-Men and women aged 16 years or older
Note: Includes patients who have visited the institution in the past. Postoperative patients are also included. Depending on the facility, the implementation may start as recently as January 2008, depending on the storage status of electronic medical records.
Key exclusion criteria
- Patients who refused to participate in this study
-Patients who have visited the hospital less than three times, including second opinions.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Mutoh |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
602-8566
Address
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5338
mimutoh@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Mutoh |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
602-8566
Address
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5338
Homepage URL
mimutoh@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Michihiro Mutoh
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
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5337
rinri@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
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）
石川消化器内科（大阪府）
埼玉医科大学総合医療センター（埼玉県）
兵庫医科大学病院（兵庫県）
近畿大学医学部附属病院（大阪府）
栃木県立がんセンター（栃木県）
札幌医科大学附属病院（北海道）
佐野病院（兵庫県）
徳島大学病院（徳島県）
愛知県がんセンター中央病院（愛知県）
愛知医科大学（愛知県）
独立行政法人国立病院機構岩国医療センター（山口県）
広島大学病院（広島県）
石川県立中央病院（石川県）
国立がん研究センター中央病院（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）
京都大学医学部附属病院（京都府）
守口敬任会病院（大阪府）
大阪国際がんセンター（大阪府）
産業医科大学病院（福岡県）
姫路赤十字病院（兵庫県）
がん・感染症センター都立駒込病院（東京都）
自治医科大学（栃木県）
群馬大学医学部附属病院（群馬県）
Cancer Institute Hospital (Tokyo)
National Cancer Center Hospital East (Chiba)
Ishikawa Gastroenterology Clinic (Osaka)
Saitama Medical Center (Saitama)
Hyogo College of Medicine Hospital (Hyogo)
Kindai University Hospital (Osaka)
Tochigi Cancer Center (Tochigi)
Sapporo Medical University Hospital (Hokkaido)
Sano Hospital (Hyogo)
Tokushima University Hospital (Tokushima)
Aichi Cancer Center Hospital (Aichi)
Aichi Medical University (Aichi)
National Hospital Organization Iwakuni Clinical Center (Yamaguchi)
Hiroshima University Hospital (Hiroshima)
Ishikawa Prefectural Central Hospital (Ishikawa)
National Cancer Center Hospital (Tokyo)
Shikoku Cancer Center (Ehime)
Shizuoka Cancer Center (Shizuoka)
Kyoto University Hospital (Kyoto)
Moriguchi Keiminkai Hospital (Osaka)
Osaka International Cancer Institute (Osaka)
University of Occupational and Environmental Health Hospital (Fukuoka)
Japanese Red Cross Society Himeji Hospital (Hyogo)
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital (Tokyo)
Jichi Medical University (Tochigi)
Gunma University Hospital (Gunma)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 20 | 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
| 2024 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2045 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective registration follow-up observational cohort study
Management information
Registered date
| 2025 | Year | 01 | Month | 19 | Day |
Last modified on
| 2025 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064859
