Liquid Biopsy-based Early Detection of Ovarian Cancer: a... | NCT06249308

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

NCT06249308

Sponsor

Fudan University

Status

Recruiting

Last Update Posted

Feb 8, 2024Actual

Enrollment

168Estimated

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Blood collection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2023Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 31, 2024

First Submission Date that Met QC Criteria

Jan 31, 2024

First Posted Date

Feb 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2024

Last Update Posted Date

Feb 8, 2024Actual

Name	Class
Shanghai Weihe Medical Laboratory Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

168Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ovarian cancer		Participants with new diagnosis of ovarian cancer, from whom a peripheral blood sample will be collected.	Other: Blood collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood collection	Other	Blood sample will be collected	Ovarian cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
The performance of pre-defined model in clinical sub-groups of interest

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hao Wen, M.D., Ph.D.	Contact	+8618017317873		wenhao_fdc@163.com

Overall Officials

Name	Affiliation	Role
Hao Wen, M.D., Ph.D.	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen Memorial Hospital	Not yet recruiting	Guangzhou	Guangdong	110042	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D010051	Ovarian Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided