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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04903665
Recruitment Status : Active, not recruiting
First Posted : May 26, 2021
Last Update Posted : July 28, 2022
Sponsor:
Collaborator:
Guangzhou Burning Rock Bioengineering Ltd.
Information provided by (Responsible Party):
Xiaohua Wu MD, Fudan University

Study Description
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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.

Condition or disease Intervention/treatment
Gynecologic Cancer Device: Multi-cancer early detection test

Study Design
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Study Type : Observational
Actual Enrollment : 495 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gynecologic Malignancies Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Prospective, Observational Study
Actual Study Start Date : February 11, 2021
Estimated Primary Completion Date : August 22, 2022
Estimated Study Completion Date : December 31, 2022
Groups and Cohorts
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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


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

Secondary Outcome Measures :
  1. Sensitivity and specificity of the multi-omics model in early detection of gynecologic cancers in different stages. [ Time Frame: 12 months ]
  2. Sensitivity and specificity of the multi-omics model in early detection of different gynecologic cancer diseases [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Plasma, white blood cells and formalin fixed, paraffin embedded (FFPE) tumor tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04903665


Locations
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China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Guangzhou Burning Rock Bioengineering Ltd.
Investigators
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Principal Investigator: Xiaohua Wu, M.D.&Ph.D Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
More Information
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Responsible Party: Xiaohua Wu MD, Director, Fudan University
ClinicalTrials.gov Identifier: NCT04903665    
Other Study ID Numbers: FDZL-2021002
First Posted: May 26, 2021    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaohua Wu MD, Fudan University:
gynecologic cancer
early detection
liquid biopsy
cell-free DNA