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

September 28, 2023 updated by: Zhong Zheng MD, Fudan University

Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study

This study is a prospective study aimed to 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 2935 female participants, including participants with gynecologic cancers patients and healthy participants.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2935

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan university shanghai cancer center, Deparment of gynecologic oncology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaohua Wu, MD.&PHD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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 healthy controls

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 within 42 days prior to blood collection
  • 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.
  • previous history of malignant tumor;
  • precancerous lesions or benign diseases confirmed by biopsy or surgical specimen;
  • unknown or insufficient to determine the nature of the lesion by histopathological reports;

Inclusion Criteria for healthy control Arm Participants:

  • Able to provide a written informed consent.
  • Able to provide sufficient and qualified blood samples for study tests.
  • No cancer related symptoms within 30 days prior to study screening.
  • Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.

Exclusion Criteria for healthy control Arm Participants:

  • Insufficient qualified blood sample for study test.
  • During pregnancy or lactation.
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
  • Recipient of blood transfusion within 30 days prior to study blood draw.
  • Recipient of anti-infectious therapy within 14 days prior to study blood draw.
  • Have received or are undergoing curative cancer treatment within three years prior to study screening.
  • With autoimmune or other diseases with severe comorbidities.

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
Cancer arm
Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected
Healthy arm
Participants without a known cancer or certain benign disease, from whom blood samples will be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.
Time Frame: 24months
24months
To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors
Time Frame: 24months
24months

Collaborators and Investigators

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

Sponsor

Fudan University

Collaborators

Guangzhou Burning Rock Dx Co., Ltd.

Investigators

  • Principal Investigator: Xiaohua Wu, MD.&PHD, 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 22, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSCD2021002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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