Liquid biopsy screening for early endometrial cancer in regional China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses a case-control design to evaluate a multi-omics cfDNA model derived from low-pass whole-genome sequencing of plasma. It will enroll 512 women across three groups: endometrial cancer patients (stages I–IV), patients with atypical endometrial hyperplasia, and healthy controls. Blood samples are collected before any treatment, cfDNA is isolated, and sequencing data are analyzed for fragment patterns, end motifs, and copy number variations to predict cancer risk and differentiate lesion types. The study aims to quantify accuracy and specificity of the cfDNA-based approach for early detection in a real-world regional population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guizhou Provincial People's Hospital
  Guiyang, Guizhou, China Recruiting

Study contacts

• Principal investigator: Yong Li, MD — Guizhou Provincial People's Hospital
• Study coordinator: Yong Li, MD
• Email: liyong7229771@163.com
• Phone: +8613628566285

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.