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

NCT06249308 | Recruiting

• 1 other identifier: PROFOUND -OC
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 3

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The performance of model using multi-omics data for discriminating ovarian cancer versus non-cancer

  12 months

• The performance of pre-defined model in clinical sub-groups of interest

  12 months

Study Arms (1)

Ovarian cancer

Participants with new diagnosis of ovarian cancer, from whom a peripheral blood sample will be collected.

Other: Blood collection

Interventions

Blood collection OTHER

Blood sample will be collected

Ovarian cancer

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed ovarian cancer or individuals with a high suspicion for OC will be invited to participate in this proof-of-concept study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Weihe Medical Laboratory Co., Ltd.: collaborator

Study Sites (3)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 110042, China

NOT YET RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hao Wen, M.D., Ph.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Wen, M.D., Ph.D.

CONTACT

+8618017317873; wenhao_fdc@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: December 18, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)