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

July 26, 2022 updated by: Xiaohua Wu MD, Fudan University

Gynecologic Malignancies Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Prospective, Observational Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

495

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer Arm
Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected.
Device: Multi-cancer early detection test
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.
Device: Multi-cancer early detection test
Blood collection and multi-cancer early detection testing

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Guangzhou Burning Rock Bioengineering Ltd.

Investigators

  • Principal Investigator: Xiaohua Wu, M.D.&Ph.D, Department of Gynecological Oncology, Fudan University Shanghai Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 11, 2021

Primary Completion (ANTICIPATED)

August 22, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (ACTUAL)

May 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDZL-2021002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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