Prospective Study for the Development, Validation and Confirmation of a Multi-Cancer Early Detection Platform Through Whole-Genome Sequencing Analysis of Circulating DNA in Cancer and Non-Cancer Subjects

NCT07598747 | Recruiting

• 1 other identifier: 4-2024-1061
• Study Type: observational
• Target: 6,000
• 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. This study was designed to establish a clinical and molecular database using circulating DNA from both cancer patients and non-cancer participants, advance and validate an artificial intelligence platform capable of detecting various types of cancer at an early stage, and evaluate its performance.

Conditions

Cancer; Healthy Participants

Outcome Measures

Primary Outcomes (1)

• To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test.

  Sensitivity, specificity, positive predictive value, and negative predictive value of the MCED test will be calculated to evaluate its diagnostic performance for cancer detection. Sensitivity is defined as the proportion of participants with cancer who test positive on the MCED assay, while specificity is defined as the proportion of participants without cancer who test negative. Positive predictive value and negative predictive value will be calculated based on the proportion of true-positive and true-negative results among all positive and negative test results, respectively.

  Assessed up to 36 months

Secondary Outcomes (2)

• To evaluate the accuracy of tumor of origin prediction of MCED test.

  Assessed up to 36 months

• To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test by stage.

  Assessed up to 36 months

Study Arms (2)

Cancer patients

Healthy volunteers

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

Cancer patients 5,000, Healthy volunteers: 1,000

You may qualify if:

• Adults aged 19 years or older
• Individuals who understand the study and voluntarily provide informed consent.
• (only for cancer participants) Participants with newly diagnosed solid tumors (Stage I-IV, including brain tumors) or hematologic malignancies who:
• Have a histologically confirmed diagnosis (including bone marrow biopsy), or
• Are highly suspected of having cancer based on clinical and/or radiologic evaluation and are scheduled for surgical resection after blood collection; and
• Have not yet initiated any treatment (chemotherapy, targeted therapy, hormonal therapy, immunotherapy, radiotherapy, surgical resection, etc.).
• (only for non-cancer participants) Individuals with no prior history of cancer.
• (only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging.

You may not qualify if:

• Pregnancy (self-reported pregnancy status).
• Individuals for whom blood collection is deemed difficult by the investigator.
• Individuals with a history of infection with HIV, HTLV, or syphilis.
• (only for non-cancer participants) Individuals diagnosed with another malignancy within the past 5 years (exceptions: non-melanoma skin cancer, in-situ malignancies, thyroid cancer, and cervical intraepithelial neoplasia treated with curative intent).
• (only for non-cancer participants) Individuals with cancer of unknown primary origin.
• (only for non-cancer participants) Individuals with synchronous or metachronous multiple primary cancers.

Sponsors & Collaborators

• Chang Gon Kim: lead

Study Sites (1)

Yonsei Cancer Center

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Chang Gon Kim

CONTACT

+82-2-2228-8130; inspector@yuhs.ac

Study Design

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

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: May 20, 2026
• Study Start: October 14, 2024
• Primary Completion (Estimated): October 13, 2029
• Study Completion (Estimated): October 13, 2032
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)