Feasibility of Multi-cancer Early Detection Test in Screening Population (NQMD-CS)

NCT07834268 | Active Not Recruiting

• 1 other identifier: GYWY-L2025-102
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multicenter screening cohort study designed to evaluate the feasibility of a blood-based multi-cancer early detection (MCED) test in an asymptomatic screening population. Eligible participants will undergo blood-based MCED testing, standard cancer screening as appropriate, and 1-year active follow-up. Participants with positive MCED results or highly suspicious findings from standard screening will undergo diagnostic evaluation to determine cancer status, enabling a more accurate assessment of the test's clinical performance.

Conditions

Colorectal Cancer; Grastic Cancer; Esophageal Cancer; Lung Cancer; Liver Cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility of MCED in the intended use setting

  Descriptive statistics will be used to summarize the number of the five pre-specified cancers diagnosed by MCED.

  From enrollment to the Follow-up at 1 year

• Safety of MCED in the intended use setting

  Descriptive statistics will be used to summarize the time to diagnostic resolution following receipt of a positive MCED result and the number and types of diagnostic tests and procedures performed during the diagnostic evaluation.

  From enrollment to the Follow-up at 1 year

Secondary Outcomes (4)

• Performance of MCED in the intended use setting.

  From enrollment to the Follow-up at 1 year

• Tissue-of-origin accuracy of MCED

  From enrollment to the Follow-up at 1 year

• Participant-reported anxiety impact

  From enrollment to the Follow-up at 1 year

• Participant-reported health related quality of life (HRQoL)

  From enrollment to the Follow-up at 1 year

Study Arms (1)

MCED-screening

EXPERIMENTAL

MCED results are returned to investigators and participants. Participants with a cancer signal undergo clinician-guided diagnostic assessment to confirm or rule out cancer

Diagnostic Test: MCED

Interventions

MCED DIAGNOSTIC_TEST

A cfDNA methylation-based early cancer detection model that provides a binary positive/negative result and predicts the tissue of origin when a cancer-associated signal is detected.

MCED-screening

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old; 2.Able to provide a written informed consent; 3.Willing to comply with all part of the protocol procedures.

You may not qualify if:

• With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen;
• Have definite contraindications of cancer screening examination and diagnostic procedures;
• Unable to comply with the protocol procedures;
• Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date;
• Recipients of anti-tumor therapy within 30 days prior to screen;
• Pregnancy or lactating women;
• Recipients of organ transplant or prior bone marrow transplant or stem cell transplant;
• Recipients of blood transfusion within 7 days prior to screen;
• With autoimmune diseases;
• Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw;
• Unsuitable for this trial determined by the researchers.

Sponsors & Collaborators

• Fifth Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (2)

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Huidong People's Hospital

Huizhou, Guangdong, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Esophageal Neoplasms; Lung Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: July 2, 2025
• Primary Completion: October 1, 2026
• Study Completion: October 1, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)