Status:
COMPLETED
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies
Lead Sponsor:
Zhujiang Hospital
Collaborating Sponsors:
Guangzhou BR
Conditions:
Hepatobiliary Malignancies
Eligibility:
All Genders
40-75 years
Brief Summary
This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancie...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All the Participants:
- 40-75 years old
- Ability to comply with study procedures
- Ability to provide a written informed consent
- Exclusion Criteria for All the 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 anti-microbial therapy within 14 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 Cancer Arm Participants:
- Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
- Exclusion Criteria for Cancer Arm Participants:
- Current diagnosis of other malignancies or multiple primary tumors
- Diagnosis of benign diseases by histopathological assessments
- Inability to characterize whether the lesion is malignant or benign
- Prior or ongoing treatment of cancer
- Inclusion Criteria for Benign Diseases Arm Participants:
- Confirmed diagnosis of benign diseases of the hepatobiliary system
- No prior radical treatment of the benign diseases prior to study blood draw
- Exclusion Criteria for Benign Diseases Arm Participants:
- Current or history of malignancies or precancerous lesions
- No confirmed diagnosis or inability to characterize a benign disease
Exclusion
Key Trial Info
Start Date :
March 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT04835675
Start Date
March 12 2021
End Date
June 30 2022
Last Update
March 2 2023
Active Locations (1)
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1
Zhujiang Hospital
Guangzhou, Guangdong, China, 510280