NCT06249308Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 168 (estimated)
- First submitted
- 31 Jan 2024
- Start date
- 18 Dec 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fudan University
- Diseases
- Ovarian cancer
- NCT number
- NCT06249308
What you commit to
- Study type: Observational
- Planned participants: 168
- From 18 Dec 2023 to the primary completion date, 31 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- Other conditions that the investigators considered are not suitable for the enrollment
Other
- Pregnancy or lactating women
Who the study is looking for
- 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
Age in the registry: 40 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Liaoning Cancer Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.