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Liquid Biopsy-Based early screening for endometrial cancer in regional chinese populations

NCT ID NCT07892755

Sponsor: Guizhou Provincial People's Hospital Source: ClinicalTrials.gov ↗

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Recruiting now This study
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Not open to general applications. Only people the study team invites can take part.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

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Not a trial. The treatment could once be requested outside a study, but no longer can.
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When the status isn't known

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First seen Oct 23, 2026 · Last updated Oct 23, 2026

Summary

Endometrial cancer is one of the most common gynecological malignancies, and its incidence is rising. Currently, there is a lack of highly effective and non-invasive screening methods. Liquid biopsy, which analyzes cell-free DNA (cfDNA) in the blood, has emerged as a promising approach for early cancer detection. This observational study aims to develop and evaluate a non-invasive blood test to screen for early-stage endometrial cancer and to distinguish between benign and malignant endometrial lesions. This study plans to enroll 512 female participants, divided into three groups: 216 patients with stage I-IV endometrial cancer, 80 patients with atypical endometrial hyperplasia (a precancerous condition), and 216 healthy controls. We will collect peripheral blood samples from all participants and perform low-pass whole-genome sequencing (WGS) on the extracted plasma cfDNA. By analyzing specific DNA features (such as DNA fragment patterns, end motifs, and copy number variations) and using artificial intelligence (machine learning), we will build a predictive model. This study hopes to establish a more effective, non-invasive early screening strategy to improve the clinical diagnosis of endometrial cancer in the Chinese population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 512 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

he study includes three cohorts: 216 patients with stage I-IV endometrial cancer, 80 patients with atypical endometrial hyperplasia, and 216 age-matched healthy female controls. All participants are recruited from regional Chinese populations.

Ages

Up to 18 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female, aged \> 18 years. Participants fully understand the study requirements and sign the written informed consent. Cohort A (Endometrial Cancer): Patients with histologically and/or cytologically confirmed stage I-IV endometrial cancer; comprehensive clinical and pathological information is available. Cohort B (Atypical Hyperplasia): Patients diagnosed with atypical endometrial hyperplasia; comprehensive clinical and pathological information is available. Cohort C (Healthy Control): Healthy female subjects with no tumors or suspicious nodules confirmed by systematic examination. Exclusion Criteria: * Pregnant women. Current diagnosis of tumors other than endometrial cancer or a history of previous tumors. Received any form of tumor treatment prior to blood draw, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy. Current febrile illness, or acute/inflammatory disease requiring internal medical treatment within 14 days prior to blood draw. Organ transplant recipients or previous recipients of allogeneic bone marrow or stem cell transplants. Poor health status or unsuitable for blood draw. Any other clinically significant disease or condition that, in the investigator's opinion, may affect protocol compliance, affect the subject's ability to sign informed consent, or make the subject unsuitable for this clinical study.

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Conditions

The condition(s) this trial relates to.

atypical endometrial hyperplasia endometrial cancer Endometrial Hyperplasia endometrium neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atypical endometrial hyperplasia Endometrial cancer

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Guizhou Provincial People's Hospital

    RECRUITING

    Guiyang, Guizhou, 550002, China

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