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Clinical Trials in South Korea / NCT06231953
Recruiting Observational

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

NCT06231953 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Observational
Started
2022-10-13
Last updated
2024-01-30

Condition(s) studied

Invasive CancerHealthy Volunteer

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value — 36 months
  • Accuracy of prediction for the origin of cancer, assessed by concordance rate — 36 months

Trial sites (1)

FacilityCityRegionStatus
Yonsei Cancer Center, Yonsei Univ. College of Medicine Seoul South Korea Recruiting

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Other trials for the same condition

A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec Active, not recruiting
A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06231953 on ClinicalTrials.gov ↗ ← All trials in South Korea