UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054120 |
|---|---|
| Receipt number | R000061798 |
| Scientific Title | Clinical Health Exploration, Research, and Information Storage for Hereditary cancers |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/04/14 10:08:30 |
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Basic information
Public title
Clinical Health Exploration, Research, and Information Storage for Hereditary cancers
Acronym
CHERISH biobank
Scientific Title
Clinical Health Exploration, Research, and Information Storage for Hereditary cancers
Scientific Title:Acronym
CHERISH biobank
Region
| Japan |
Condition
Condition
hereditary cancers
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Ophthalmology | Dermatology |
| Psychiatry | Oto-rhino-laryngology | Orthopedics |
| Urology | Radiology | Anesthesiology |
| Oral surgery | Neurosurgery | Cardiovascular surgery |
| Plastic surgery | Laboratory medicine | Operative medicine |
| Blood transfusion | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Samples of peripheral blood, oral mucosa, skin tissue, etc. obtained from research participants are collected and stored for those who have undergone genetic testing after genetic counseling. In addition, approximately 1623 existing samples (as of November 1, 2023) which have been collected and stored in our department will be inherited and used.Clinical information and associated analytical information, will be also collected and stored to serve as a resource for various ongoing and planned future studies.
Basic objectives2
Others
Basic objectives -Others
To collect analytical and clinical information to clarify trends in incidence, surveillance, treatment, and prognosis of hereditary cancer syndromes in Japan, as well as psychosocial factors associated with genetic counseling recipients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Extract electronic and paper medical records from each departmental system.
a. Clinical findings (age, sex, height, weight, tumor differentiation, information on medical history, clinical stage, test results, imaging results, etc.)
b. Treatment and prognostic information: drugs administered, response, duration of treatment, presence or absence and details of radiotherapy and surgery, presence or absence of recurrence/metastasis, form of recurrence, date of confirmation of recurrence, outcome (alive, death from primary/unknown disease, death from other disease, date of confirmation), etc.
c. Genetic test details, analysis data, variant information, and results (including revised reports)
d. genealogical information (family history, family tree, information on diseases of family members, etc.)
e. Descriptive records on medical records (genetic counseling records, questionnaires, interview records, etc.)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
In this study, blood samples will be collected mainly in conjunction with genetic testing and, less frequently, saliva and other body fluids, skin, oral mucosa, etc. will be collected. In the case of blood collection, needle sticks will not be used only for this study in principle, and the volume of blood collected will increase by approximately 5 mL per sample. However, these are not expected to affect the symptoms or course of treatment of the participants. There is a risk of vasovagal reflex during blood collection, but it is infrequent. In the case of sample collection from oral mucosa, it is virtually noninvasive but may be accompanied by minor bleeding.
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
Samples will be collected from those who have provided genetic counseling and undergone genetic tests, etc. at Cancer Institute Hospital (including those who have not yet developed cancer).
The participants of observational studies using clinical information are those who have undergone genetic counseling at the Department of Clinical Genetic Oncology, Cancer Institute Hospital, either in person or online, or who have undergone BRCA1/2 testing, homologous recombination deficiency (HRD) testing, microsatellite instability (MSI), or other tests as part of their cancer treatment in our hospital. And also those who have undergone cancer genomic profiling tests such as FoundationOne CDx, OncoGuide diagnostic system, NCC OncoPanel system, FoundationOne Liquid CDx, etc. and other research analyses (including whole genome analysis) in our hospital, by visiting the Cancer Institute Hospital Genome Clinical Department.
Key exclusion criteria
The withdrawal request will not be accepted if the research is in progress at the time the withdrawal request is made, the information has already been analyzed and entered into a public database, or the information cannot be connected to a person as a result of processing to prevent identification of a specific person.
The possibility that the sample or information cannot be disposed of even if a withdrawal request is made is stated in the explanatory documents.
The information should be explained in the explanatory document.
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Arisa |
| Middle name | |
| Last name | Ueki |
Organization
The Cancer Institute Hospital of JFCR
Division name
Department of Clinical Genetic Oncology
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
arisa.ueki@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Arisa |
| Middle name | |
| Last name | Ueki |
Organization
The Cancer Institute Hospital of JFCR
Division name
Department of Clinical Genetic Oncology
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
Homepage URL
arisa.ueki@jfcr.or.jp
Sponsor or person
Institute
The Cancer Institute Hospital of JFCR
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Cancer Institute Hospital of JFCR
Address
3-8-31 Ariake, Koto-ku, Tokyo
Tel
03-3520-0111
med.shinsa@jfcr.or.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | 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 | 02 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061798
