Status:
UNKNOWN
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-I
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Guangzhou Burning Rock Bioengineering Ltd.
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18+ years
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 mutat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT04903665
Start Date
February 11 2021
End Date
December 31 2022
Last Update
July 28 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032