UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053874 |
|---|---|
| Receipt number | R000061493 |
| Scientific Title | Peutz-Jeghers Syndrome Prospective Registration Cohort Study (National registration of the Peutz-Jeghers Syndrome Subcommittee of the Japanese Society for Hereditary Tumors and the Ministry of Health, Labor and Welfare's Intractable Disease Policy Research Project "Research to improve medical standards and QOL of patients with a high incidence of gastrointestinal hamartomatous tumors in children to adults" Joint research) |
| Date of disclosure of the study information | 2024/03/15 |
| Last modified on | 2024/03/16 06:37:39 |
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Basic information
Public title
Peutz-Jeghers Syndrome Prospective Registration Cohort Study (National registration of the Peutz-Jeghers Syndrome Subcommittee of the Japanese Society for Hereditary Tumors and the Ministry of Health, Labor and Welfare's Intractable Disease Policy Research Project "Research to improve medical standards and QOL of patients with a high incidence of gastrointestinal hamartomatous tumors in children to adults" Joint research)
Acronym
Peutz-Jeghers Syndrome Prospective Registration Cohort Study
Scientific Title
Peutz-Jeghers Syndrome Prospective Registration Cohort Study (National registration of the Peutz-Jeghers Syndrome Subcommittee of the Japanese Society for Hereditary Tumors and the Ministry of Health, Labor and Welfare's Intractable Disease Policy Research Project "Research to improve medical standards and QOL of patients with a high incidence of gastrointestinal hamartomatous tumors in children to adults" Joint research)
Scientific Title:Acronym
Peutz-Jeghers Syndrome Prospective Registration Cohort Study
Region
| Japan |
Condition
Condition
Peutz-Jeghers Syndrome
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Pediatrics |
| Dermatology | Adult | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will register information and clinical data on patients with Peutz-Jeghers syndrome in Japan, and investigate the frequency of Peutz-Jeghers syndrome, clinicopathological characteristics, and complications such as organ-specific cancer risk. In addition, the attending physician conducts a prospective study every year to check for the presence of cancer, organ damage, complications, etc., in order to ascertain the prognosis.
Basic objectives2
Others
Basic objectives -Others
Cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastrointestinal endoscopy findings (Esophagogastroduodenoscopy, Colonoscopy, Enteroscopy)
Key secondary outcomes
Age, family members with the same disease, estimated date of onset, date of confirmed diagnosis, length of hospital visit, first medical institution, diagnostic medical institution, status of medical treatment received in the past year, transition of cases diagnosed under the age of 15 from the pediatric department to the adult department, medical history, drinking history, smoking history, physical activity level, employment/schooling status, diagnosis trigger, Hb, Alb, small intestine imaging examination, endoscopic treatment details, adverse events of endoscopic treatment, abdominal surgery history, history of intussusception, history of gastrointestinal malignancy, history of endometrial cancer, history of cervical cancer, history of testicular cancer, history of ovarian cancer, history of pancreatic cancer, history of breast cancer, history of lung cancer, history of other malignant tumors, presence or absence of pigment spots, history of pigment spot treatment, genetic testing history, application history for specific pediatric chronic diseases
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with Peutz-Jeghers syndrome
Key exclusion criteria
Patients whose consent cannot be obtained
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Sakamoto |
Organization
Jichi Medical University
Division name
Department of Medicine, Division of Gastroenterology
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken
TEL
0285587348
94036hs@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Michishita |
Organization
Medical Research Support Co., Ltd.
Division name
Data Management Department
Zip code
5410043
Address
3-1-14-6F Koraibashi, Chuo-ku, Osaka 541-0043, Japan
TEL
06-6202-5446
Homepage URL
michishita-atsu@medical-rs.com
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Japanese Society for Hereditary Tumors
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Investigation Jichi MEdical University Hospital
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken
Tel
0285-58-8933
rinri@jichi.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
自治医科大学附属病院（栃木県）、信州大学医学部附属病院（長野県）、岡山大学病院（岡山県）、埼玉医科大学総合医療センター（埼玉県）、石川県立中央病院（石川県）、九州大学病院（福岡県）、徳島大学病院（徳島県）、大阪医科薬科大学病院（大阪府）、埼玉県立小児医療センター（埼玉県）、藤田医科大学病院（愛知県）、佐賀大学医学部附属病院（佐賀県）、群馬大学医学部附属病院（群馬県）、順天堂大学医学部附属順天堂医院（東京都）、横浜市立大学附属市民総合医療センター（神奈川県）、石川消化器内科（大阪府）、がん・感染症センター都立駒込病院（東京都）、山形大学医学部附属病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 15 | 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 | 03 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Co-researchers will directly request recruitment from Peutz-Jeghers syndrome patients attending each research institution. In addition, the fact that this research is being conducted will be posted on the "Research to improve medical standards and QOL of patients with a high incidence of gastrointestinal hamartomatous tumors in children and adults" group homepage (https://polyposis.jp/). . The clinical information to be considered will be collected by co-researchers from the medical records of each research institution, using a separate questionnaire, and collected at a data center (Medical Research Support Ltd.). In addition, for cases in which STK11 gene variants have been measured in clinical practice and recorded on the medical record, the results will also be collected as part of the clinical information. If there is a family member with the same disease (up to third-degree relatives), collect clinicopathological information regarding Peutz-Jeghers syndrome (presence or absence of neoplastic lesions, type, and age at diagnosis).
Management information
Registered date
| 2024 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061493
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
