Trials / Recruiting
RecruitingNCT06249308
Liquid Biopsy-based Early Detection of Ovarian Cancer: a Proof-of-concept Study ( PROFOUND-OC )
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 168 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- Female
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Blood collection | Blood sample will be collected |
Timeline
- Start date
- 2023-12-18
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
- First posted
- 2024-02-08
- Last updated
- 2024-02-08
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06249308. Inclusion in this directory is not an endorsement.