Clinical Health Exploration, Research, and Information Storage for Hereditary cancers

UMIN ID: UMIN000054120

Registered date:01/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: hereditary cancers
• Date of first enrollment: 2024/04/01
• Target sample size: 8000
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: 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 inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: The Cancer Institute Hospital of JFCR
• Source(s) of Monetary Support: none