AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)

December 28, 2022 updated by: Xiaoqing Jiang, Eastern Hepatobiliary Surgery Hospital

Exploration and Validation of a Diagnosis Model for Biliary Tract Cancer Based on Combined Liquid Biopsy in Peripheral Blood: A Multi-center Prospective Study

ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

492

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
        • Contact:
          • Leibo Xu, MD/PhD
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Recruiting
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible participants will be recruited from participating medical centers and assigned into two arms, including participants with new diagnosis of biliary tract cancer and benign biliary tract diseases.

Description

Inclusion Criteria for Cancer Arm Participants:

  • Age 40-75 years at the day of consenting to the study.
  • Able to provide a written informed consent
  • Pathologically confirmed biliary tract cancers.
  • 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 cancers.
  • With other known malignant tumors or multiple primary tumors.

Inclusion Criteria for Benign Arm Participants:

  • Age 40-75 years at the day of consenting to the study.
  • Able to provide a written informed consent.
  • Confirmed diagnosis of benign biliary tract 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 cancers.
  • Confirmed diagnosis of malignancies or precancerous lesion.
  • A history of malignant tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer arm
Baseline blood samples will be collected from participants newly diagnosed with biliary tract cancer.
Other: Blood drawing
Blood drawing before anti-cancer therapy
Other: Blood drawing
Blood drawing before radical treatment
Benign disease arm
Baseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases.
Other: Blood drawing
Blood drawing before anti-cancer therapy
Other: Blood drawing
Blood drawing before radical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The sensitivity and specificity of the combined model in detection of biliary tract cancers.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The sensitivity and specificity of the combined model in detection of different subtypes of biliary tract cancers.
Time Frame: 24 months
24 months
The sensitivity and specificity of the combined model in detection of different stages of biliary tract cancers.
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Collaborators

Guangzhou Burning Rock Bioengineering Co., Ltd

Investigators

  • Principal Investigator: Xiaoqing Jiang, MD/PhD, Eastern Hepatobiliary Surgery Hospital
  • Principal Investigator: Bin Li, MD/PhD, Eastern Hepatobiliary Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

December 30, 2022

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSCD2021021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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