Status:
UNKNOWN
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-II
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Guangzhou Burning Rock Dx Co., Ltd.
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
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 bloo...
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 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.
Exclusion
Key Trial Info
Start Date :
February 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
2935 Patients enrolled
Trial Details
Trial ID
NCT06001099
Start Date
February 22 2023
End Date
December 31 2024
Last Update
September 29 2023
Active Locations (1)
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1
Fudan university shanghai cancer center, Deparment of gynecologic oncology
Shanghai, Shanghai Municipality, China, 200032