Liquid Biopsy-based Early Detection of Ovarian Cancer: a Proof-of-concept Study ( PROFOUND-OC )

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Other: Blood collection

• Registration Number: NCT06249308
• Lead Sponsor: Fudan University

Brief Summary

This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from newly diagnosed ovarian cancer.

Detailed Description

Peripheral blood samples from ovarian cancer (OC) patients will be prospectively collected to identify cancer-specific circulating signals by analyzing cell free DNA. Based on the comprehensive molecular profiling, a machine learning-driven noninvasive test will be trained and validated through a two-stage approach in clinically annotated individuals. Approximately 168 stage I-II OC patients will be enrolled in this study. Age-matched female controls included in model development were recruited in another study, which are volunteers without a cancer diagnosis after routine medical screening.

Study Timeline

• Study Start: 2023-12-18
• Status Verified: 2024-01
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 168

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ovarian cancer	Blood collection	Participants with new diagnosis of ovarian cancer, from whom a peripheral blood sample will be collected.

Primary Outcome Measures

Name	Time	Method
The performance of cfDNA methylation-based model for discriminating ovarian cancer versus non-cancer.	12 months	Sensitivities of cfDNA methylation-based model in detecting OC at specificity of 99% and 95%, respectively.

Secondary Outcome Measures

Name	Time	Method
The performance of model using multi-omics data for discriminating ovarian cancer versus non-cancer	12 months	Sensitivities of multi-omics model which combines methylation signature and fragmentomic features in detecting OC at specificity of 99% and 95%, respectively.
The performance of pre-defined model in clinical sub-groups of interest	12 months	Sensitivity of pre-defined model in different pathological subtypes or different age groups or tumor marker-negative cases.

Trial Locations

Locations (3)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Liaoning Cancer Hospital & Institute; 🇨🇳 Shenyang, Liaoning, China

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China