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A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers

Not Applicable
Recruiting
Conditions
Not Applicable
Registration Number
KCT0008484
Lead Sponsor
Yonsei University Health System, Severance Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
4000
Inclusion Criteria

Subjects prior to the start of treatment for stages 1 to 4 of various solid carcinomas or healthy adults who have scheduled a cancer medical examination
- Men and women over 19 years of age
- Subjects and healthy adults who agree to collect and analyze clinical information and human-derived materials for research purposes, and agree to store residual blood samples and use them for secondary research purposes
- Subjects who can donate blood without harming their health
- Subjects who understand and voluntarily agree to this study

Exclusion Criteria

- Subjects under the age of 19
- Vulnerable subjects with mental retardation or severe psychiatric conditions
- Subjects who are unable to participate in the study due to other reasons as determined by the researcher
- Subjects with a history of HIV, HTLV, and Syphilis infection
- Subjects diagnosed with primary unknown cancer or multiple cancers
- Subjects diagnosed with other malignant tumor within 5 years(except for non-melanoma skin cancer treated for cure, in-situ disease treated for cure, thyroid cancer, or intraepithelial carcinoma of the cervix)

Study & Design

Study Type
Observational Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Developing an analysis platform that can be used for early screening of some cancers
Secondary Outcome Measures
NameTimeMethod
Establishing a whole-genome sequencing(circulating DNA in blood) and clinical information database from 1,500 cancer subjects and 500 healthy adults
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