Early detection of ovarian cancer using liquid biopsy

A Multi-center, Perspective, Observational Case-control Study to Develop and Validate an Ovarian Cancer Early Detection Model Based on Peripheral Blood Multi-omic Analysis and Machine Learning

This study is testing a new blood test to see if it can help find ovarian cancer earlier in women who have just been diagnosed.

Quick facts

• Study type: Observational
• Enrollment: 168 (estimated)
• Ages: 40 Years to 75 Years
• Sex: Female
• Sponsor: Fudan University (other)
• Drugs / interventions: immunotherapy
• Locations: 3 sites (Guangzhou, Guangdong and 2 other locations)
• Trial ID: NCT06249308 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop a machine learning-based model for the early detection of ovarian cancer by analyzing liquid biopsy samples from newly diagnosed patients. Peripheral blood samples will be collected from approximately 168 stage I-II ovarian cancer patients to identify cancer-specific signals through the analysis of cell-free DNA. The study will utilize a two-stage approach for training and validating a noninvasive test based on comprehensive molecular profiling. Age-matched female controls without cancer will also be included in the model development.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 40-75 who have been clinically or pathologically diagnosed with ovarian cancer and have not received any prior antitumor therapy.

Not a fit: Patients who are pregnant, lactating, or have other malignancies or severe infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a noninvasive method for early detection of ovarian cancer, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection, but this specific approach is novel and untested.

Eligibility criteria

Inclusion Criteria:

* 40-75 years old
* Clinically and/or pathologically diagnosed ovarian cancer
* 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.
* Able to provide a written informed consent and willing to comply with all part of the protocol procedures

Exclusion Criteria:

* Pregnancy or lactating women
* Known prior or current diagnosis of other types of malignancies comorbidities
* Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
* Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 30 days prior to study blood draw
* Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
* Other conditions that the investigators considered are not suitable for the enrollment

Where this trial is running

Guangzhou, Guangdong and 2 other locations

• Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Hao Wen, M.D., Ph.D. — Fudan University
• Study coordinator: Hao Wen, M.D., Ph.D.

Conditions: Ovarian Cancer