AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies

NCT ID: NCT04835675

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

496 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-12

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatobiliary Malignancies

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer Arm

Participants with new diagnosis of hepatobiliary malignancies, from whom blood samples will be collected

Multi-cancer early detection test

Intervention Type DEVICE

Blood collection and multi-cancer early detection testing

Benign Diseases Arm

Participants with benign diseases of the hepatobiliary system, from whom blood samples will be collected

Multi-cancer early detection test

Intervention Type DEVICE

Blood collection and multi-cancer early detection testing

Interventions

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Multi-cancer early detection test

Blood collection and multi-cancer early detection testing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 40-75 years old
* Ability to comply with study procedures
* Ability to provide a written informed consent


* Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies
* No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw


* Confirmed diagnosis of benign diseases of the hepatobiliary system
* No prior radical treatment of the benign diseases prior to study blood draw

Exclusion Criteria

* 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


* 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


* Current or history of malignancies or precancerous lesions
* No confirmed diagnosis or inability to characterize a benign disease
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou BR

UNKNOWN

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mingxin Pan

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital

Locations

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Zhujiang Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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ZJYY-2020006

Identifier Type: -

Identifier Source: org_study_id

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