Healthy Volunteer Clinical Trial
Official title:
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.
NCT number | NCT06231953 |
Other study ID # | 4-2022-0299 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 13, 2022 |
Est. completion date | December 2026 |
Verified date | January 2024 |
Source | Yonsei University |
Contact | Joohyuk Sohn |
Phone | +82-2-2228-8135 |
oncosohn[@]yuhs.ac | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA. The study will enroll 4,000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea.
Status | Recruiting |
Enrollment | 4000 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Aged 19 years or older - Subjects who have been diagnosed with stages 1 to 4 of solid tumor or healthy volunteers who have scheduled a cancer screening examination - Subjects who have agreed to provide clinical information and blood samples - Subjects who have agreed for the storage and secondary use of residual blood samples for research - Subjects who have understood the study and are able to provide a written informed consent Exclusion Criteria: - Subjects who are not appropriate for the study because of intellectual disabilities or severe mental disorders - Subjects with a history of HIV, HTLV, or Syphilis infection - Subjects with primary site unknown cancer or synchronous or metachronous double primary cancers - Subjects who have diagnosed with any other malignant tumor within the past 5 years (except for cured non-melanoma skin cancer, in situ cancer, or thyroid cancer) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei Cancer Center, Yonsei Univ. College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value | 36 months | ||
Primary | Accuracy of prediction for the origin of cancer, assessed by concordance rate | 36 months |
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