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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Healthy Participants

Detailed Description

Written informed consent will be obtained from each participant, and screening will begin after obtaining consent according to the study's inclusion and exclusion criteria.

The informed consent form (ICF) approved by each institution's IRB/EC must be used, and a copy of the signed ICF will be provided to the participant.

For participants who meet the eligibility criteria (meeting all inclusion criteria and none of the exclusion criteria), 20 mL of peripheral whole blood will be collected via standard venipuncture; the time of blood collection will be considered the time of study enrollment.

The collected 20 mL of blood will be divided into two Streck tubes (approximately 10 mL per tube) and must be handled, stored, and submitted according to the most recent laboratory manual.

Cancer participants: Blood will be collected before initiation of any treatment (surgery, chemotherapy, etc.) following cancer diagnosis.

Non-cancer participants: Blood will be collected during routine health examinations.

For domestic (Korean) cases, collected specimens should be stored at room temperature and transported as whole blood (without centrifugation) to the location designated by the sponsor by the following day after collection.

Clinical data of participants (cancer patients and healthy adults)-including sex, age, race, medical history, laboratory tests, imaging, and pathology results-will be collected in the electronic case report form (eCRF).

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Chang Gon Kim; Phone Number: +82-2-2228-8130; Email: inspector@yuhs.ac

Study Locations

• South Korea
  • Seoul, South Korea, 03722
    • Recruiting
    • Yonsei Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Adults aged 19 years or older
2. Individuals who understand the study and voluntarily provide informed consent.

3. (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.).
4. (only for non-cancer participants) Individuals with no prior history of cancer.
5. (only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging.

Exclusion Criteria:

1. Pregnancy (self-reported pregnancy status).
2. Individuals for whom blood collection is deemed difficult by the investigator.
3. Individuals with a history of infection with HIV, HTLV, or syphilis.
4. (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).
5. (only for non-cancer participants) Individuals with cancer of unknown primary origin.
6. (only for non-cancer participants) Individuals with synchronous or metachronous multiple primary cancers.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy volunteers
Cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the accuracy of tumor of origin prediction of MCED test.	To assess whether tumor of origin predictions from the MCED test are concordant with clinically diagnosed tumor types. The numbers of concordant and discordant cases will be summarized to evaluate prediction accuracy.	Assessed up to 36 months
To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test by stage.	Sensitivity, specificity, positive predictive value, and negative predictive value of the MCED test will be calculated according to cancer stage to evaluate stage-specific diagnostic performance.	Assessed up to 36 months

Collaborators and Investigators

• Sponsor: Chang Gon Kim

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): October 13, 2029
• Study Completion (Estimated): October 13, 2032

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 4-2024-1061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No