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 | Recruiting

• 1 other identifier: 4-2022-0299
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Invasive Cancer; Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cancer patients

Patients who have diagnosed as invasive cancers

Healthy volunteers

Subjects who have done cancer screening tests

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have diagnosed invasive cancer or healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center, Yonsei Univ. College of Medicine

Seoul, South Korea

RECRUITING

Study Officials

• Joohyuk Sohn

  Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joohyuk Sohn

CONTACT

+82-2-2228-8135; oncosohn@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: January 30, 2024
• Study Start: October 13, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)