Clinical trial NCT04835675: AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies
Official title: Development and Validation of the Performance of a cfDNA Methylation-based Model Combined With Serum Tumor Markers for Early Hepatobiliary Malignancies Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatobiliary Malignancies
Keywords: Hepatobiliary malignancies
Liquid biopsy
Cell-free DNA
Early detection
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou BR
First posted: 2021-04-08
Enrollment: 496
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of hepatobiliary malignancies and benign diseases of the hepatobiliary system.

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 malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98%
timeFrame: 16 months
measure: Sensitivity and specificity of early hepatobiliary malignancies detection and TOO accuracy of a cfDNA methylation-based model combined with serum tumor markers
timeFrame: 16 months
Secondary outcomes:
measure: Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in early detection of hepatobiliary malignancies in different stages
timeFrame: 16 months
measure: Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers, clinical characteristics and other biomarkers
timeFrame: 16 months
measure: Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with malignant or benign diseases of the hepatobiliary system
timeFrame: 16 months
measure: Sensitivity and specificity of a cfDNA methylation-based model or serum tumor markers in participants with hepatobiliary malignancies
timeFrame: 16 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Mingxin Pan
role: PRINCIPAL_INVESTIGATOR
References: