Detecting endometrial cancer early using blood tests

A Prospective Study of Early Detection of Endometrial Cancer Using Plasma Cell-free DNA Fragmentomics

This study is testing a new blood test to see if it can help find endometrial cancer early in people who are at high risk.

Quick facts

• Study type: Observational
• Enrollment: 216 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06083779 on ClinicalTrials.gov

What this trial studies

This study aims to develop a non-invasive method for early detection of endometrial cancer in high-risk populations by utilizing plasma cell-free DNA fragmentomics. It will involve whole-genome sequencing of plasma cell-free DNA from patients diagnosed with early-stage endometrial cancer and healthy individuals. The study will assess various features such as fragment size distribution and copy number variation to create a multimodal machine learning model for accurate detection. This approach seeks to improve upon existing screening methods that currently have low specificity and high false-positive rates.

Who should consider this trial

Good fit: Ideal candidates include women aged 18 and older diagnosed with early to mid-stage endometrial cancer or healthy individuals without any tumors.

Not a fit: Patients who are pregnant, breastfeeding, or have a history of other cancers or prior cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a reliable early detection method for endometrial cancer, potentially improving patient outcomes through earlier intervention.

How similar studies have performed: While there is ongoing research in the field of cancer detection using plasma DNA, this specific approach utilizing fragmentomics for endometrial cancer detection is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age minimum 18 years
* Patients diagnosed with early to mid-stage endometrial cancer (more than 50% are in FIGO stages I/II) through histological and/or cytological examination.
* Ability to understand and the willingness to sign a written informed consent document
* Participants can obtain comprehensive clinical and pathological information.
* Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening

Exclusion Criteria:

* Participants must not be pregnant or breastfeeding
* Participants must not have prior cancer histories or a second non-endometrial malignancy
* Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy
* Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection
* Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation
* Participants with clinically important abnormalities or conditions unsuitable for blood collection
* Any other disease or clinical condition of participants that the researcher believes may affect the compliance of the protocol, or affect the patient's signing of the informed consent form (ICF), which is not suitable to participate in this clinical trial.

Where this trial is running

Guangzhou, Guangdong

• The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Bingzhong Zhang, MD — The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Study coordinator: Bingzhong Zhang, MD

Conditions: Endometrial Cancer, Early Stage, Plasma Cell-free DNA, Fragmentomic assay