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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249308
• Other study ID #: PROFOUND -OC
• Status: Recruiting
• Start date: December 18, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Fudan University
• Contact: Hao Wen, M.D., Ph.D.
• Phone: +8618017317873
• Email: wenhao_fdc[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• Blood collection
Blood sample will be collected

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Shanghai Weihe Medical Laboratory Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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