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

NCT ID: NCT04903665

Last Updated: 2022-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

495 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-11

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Gynecologic Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer Arm

Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected.

Multi-cancer early detection test

Intervention Type DEVICE

Blood collection and multi-cancer early detection testing

Benign Arm

Participants with new diagnosis of benign gynecologic diseases, from whom blood samples will be collected.

Multi-cancer early detection test

Intervention Type DEVICE

Blood collection and multi-cancer early detection testing

Interventions

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Multi-cancer early detection test

Blood collection and multi-cancer early detection testing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Burning Rock Bioengineering Ltd.

INDUSTRY

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xiaohua Wu MD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaohua Wu, M.D.&Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Gynecological Oncology, Fudan University Shanghai Cancer Center

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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FDZL-2021002

Identifier Type: -

Identifier Source: org_study_id

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