PERformance of Multi-Cancer Early-detectIon Based on Vari... | NCT04903665

Studies
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-I

NCT04903665

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Jul 28, 2022Actual

Enrollment

495Actual

Phase

Not provided

Conditions

Gynecologic Cancer

Interventions

Multi-cancer early detection test

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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2021Actual

Primary Completion Date

Aug 22, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

May 24, 2021

First Submission Date that Met QC Criteria

May 24, 2021

First Posted Date

May 26, 2021Actual

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

Jul 26, 2022

Last Update Posted Date

Jul 28, 2022Actual

Name	Class
Guangzhou Burning Rock Bioengineering Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 prospective study aimed to develop and validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 495 female participants, including participants with gynecologic cancers or benign diseases.

Detailed Description

Not provided

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

495Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer Arm		Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected.	Device: Multi-cancer early detection test
Benign Arm		Participants with new diagnosis of benign gynecologic diseases, from whom blood samples will be collected.	Device: Multi-cancer early detection test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multi-cancer early detection test	Device	Blood collection and multi-cancer early detection testing	Benign Arm Cancer Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of the multi-omics model in early detection of gynecologic cancers in different stages.		12 months
Sensitivity and specificity of the multi-omics model in early detection of different gynecologic cancer diseases		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria for Cancer Arm Participants:

Age 18 years or older
Able to provide a written informed consent
Confirmed diagnosis or highly suspicious cases of gynecologic malignancies
No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

Pregnancy or lactating women
Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
Recipients of blood transfusion within 7 days prior to study blood draw
Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer

Inclusion Criteria for Benign Arm Participants:

Age 18 years or older
Able to provide a written informed consent
Confirmed diagnosis of benign gynecologic diseases
No prior radical treatment of the benign diseases prior to study blood draw

Exclusion Criteria for Benign Arm Participants:

Pregnancy or lactating women
Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
Recipients of blood transfusion within 7 days prior to study blood draw
Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Eligible participants will be recruited from the participating medical center and assigned into two arms, including participants with new diagnosis of gynecologic malignancies and benign gynecologic diseases.

Sampling Method

Non-Probability Sample