Performance of Multi-Cancer Detection Test in Asymptomatic Patients With Neoplastic Lesions

October 29, 2026 updated by: Rui-hua Xu, MD, PhD, Sun Yat-sen University

Performance Validation of a Blood-Based Multi-Cancer Early Detection Model in Asymptomatic Patients With Cancer and Precancerous Lesions: A Multicenter Case-Only Study

This multicenter, observational case-only study will evaluate the clinical performance of a blood-based, cell-free DNA (cfDNA) methylation multi-cancer early detection (MCED) test in adults aged 50 to 74 years with confirmed invasive cancer or selected high-risk precancerous lesions/carcinoma in situ.

The study will primarily recruit patients who had no cancer-related symptoms before diagnosis. An additional tissue-of-origin (TOO) model optimization cohort will include patients with urothelial cancer, colorectal advanced adenoma, gastric high-grade dysplasia, or esophageal high-grade dysplasia, irrespective of symptom status.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Previous case-control studies have shown promising performance in patients with established cancer diagnoses. However, conventional case-control studies predominantly enroll symptomatic patients, whose tumor burden and circulating tumor DNA (ctDNA) levels may differ from those of asymptomatic patients, even at the same cancer stage. Consequently, the sensitivity and tissue-of-origin (TOO) accuracy observed in conventional case-control studies may not fully reflect test performance in the intended screening setting. Further evaluation in asymptomatic patients with cancer is therefore needed to better characterize the technical performance of MCED tests.

This multicenter, observational, case-only study aims to evaluate the performance of a cfDNA methylation-based MCED model in patients with asymptomatic cancers and selected high-risk precancerous lesions or carcinoma in situ. The study will also support targeted optimization of the TOO prediction model for selected disease categories.

Approximately 948 participants are planned for consent and pre-treatment blood sampling. MCED test results will not be disclosed to participants or treating investigators or used to guide clinical management. The study is expected to provide additional evidence on the technical performance of cfDNA methylation-based MCED testing in asymptomatic patients and to support further model development and clinical evaluation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
948

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from hospitals: inpatient and outpatient

Description

Asymptomatic Cohort

Inclusion Criteria:

  1. Clinically and/or pathologically diagnosed with any one of the 13 invasive cancers including lung cancer, gastric cancer, etc., or diagnosed with high-risk precancerous lesions / carcinoma in situ corresponding to these 13 cancers.
  2. 50-74 years old.
  3. Self-reported absence of prespecified symptoms related to the corresponding cancer prior to diagnosis.
  4. No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc
  5. Able to provide a written informed consent and willing to comply with all part of the protocol procedures

Exclusion Criteria:

  1. Female subjects with self-reported pregnancy.
  2. Severe infection within 14 days before screening.
  3. Recipients of blood transfusion within 7 days prior to screen
  4. With active autoimmune disease, such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, etc.
  5. Other conditions judged by the investigator to render the subject ineligible for participation in this study.

TOO Model Optimization Cohort:

Inclusion Criteria:

  1. Clinically and/or pathologically diagnosed with any of the following diseases: urothelial carcinoma of the bladder, advanced colorectal adenomas, high-grade gastric intraepithelial neoplasia, or high-grade esophageal intraepithelial neoplasia
  2. 50-74 years old.
  3. No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc
  4. Able to provide a written informed consent and willing to comply with all part of the protocol procedures.

Exclusion Criteria:

  1. Female subjects with self-reported pregnancy.
  2. Severe infection within 14 days before screening.
  3. Recipients of blood transfusion within 7 days prior to screen
  4. With active autoimmune disease, such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, etc.
  5. Other conditions judged by the investigator to render the subject ineligible for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_ONLY
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Asymptomatic Cohort
Other: MCED

A cfDNA methylation-based multi-cancer early detection (MCED) test designed to screen for 16 cancer types in a single assay.
TOO Model Optimization Cohort
Other: MCED

A cfDNA methylation-based multi-cancer early detection (MCED) test designed to screen for 16 cancer types in a single assay.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity of Cancer Signal Detection (CSD)
Time Frame: 6 months after the completion of enrollment

The proportion of participants with a positive CSD result among those with clinically and/or pathologically confirmed eligible diseases, calculated overall and by disease category, with corresponding 95% confidence intervals.
6 months after the completion of enrollment
Accuracy of Tissue-of-Origin (TOO) Prediction
Time Frame: 6 months after the completion of enrollment

The proportion of CSD-positive participants whose predicted TOO category matches the clinically and/or pathologically confirmed disease site, calculated overall and by disease category, with corresponding 95% confidence intervals.
6 months after the completion of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Genie-Priori-I

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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