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Not yet recruitingNCT07915271Updated Nov 4, 2026

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

An observational study in Cancer, Precancerous Lesion and Carcinoma in Situ, sponsored by Sun Yat-sen University. Not yet recruiting. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Primary conditionCarcinoma in SituRegistry: NeoplasmsReclassifiedWhy we changed it
Registry
Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Carcinoma in Situ
Why
  1. The study's listed conditions name Carcinoma in Situ, a narrower term within Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Sun Yat-sen University · Observational

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
948
Ages
50 Years to 74 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Cancer
  • Precancerous Lesion
  • Carcinoma in Situ

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03

In context

Carcinoma in Situ Reclassified

78 studies on the registry are indexed under Carcinoma in Situ; 22 are open to participants now.

This study's planned enrollment of 948 is above the median of 162 across 13 observational studies indexed under Carcinoma in Situ.

Browse Carcinoma in Situ studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.

Browse Sun Yat-sen University studies →

Compared within Carcinoma in Situ, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients from hospitals: inpatient and outpatient

Eligibility criteria

Asymptomatic Cohort

Inclusion Criteria:

  1. Clinically and/or 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 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
948 participants (estimated)
Patient registry
No

Groups and cohorts

  • Asymptomatic Cohort

    Other: MCED

  • TOO Model Optimization Cohort

    Other: MCED

Interventions

  • OtherMCED

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

06

What researchers measure

Primary outcomes

  1. Sensitivity of Cancer Signal Detection (CSD)

    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.

    Time frame: 6 months after the completion of enrollment

  2. Accuracy of Tissue-of-Origin (TOO) Prediction

    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.

    Time frame: 6 months after the completion of enrollment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2026
First posted
Nov 4, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Aug 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07915271
Lead sponsor
Sun Yat-sen University
Responsible party
Rui-hua Xu, MD, PhD (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Nov 4, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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