Molecular Epidemiology of Biliary Tree Cancers

April 14, 2026 updated by: M.D. Anderson Cancer Center
This study is to learn if certain risk factors (environmental, viral, behavioral, medical, and dietary), tumor markers, and genetic changes can predict the development and outcome of biliary tree cancers. Establishing biomarkers models from patients may help doctors to further understand how biliary tree cancer is affected by different treatments, and why some people's cancer responds differently than others.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To identify significant factors that may contribute to the etiology of biliary tree cancer.

II. To identify novel genetic loci that predispose to gallbladder cancers (GBC) and cholangiocarcinoma (CGC) diagnosis.

EXPLORATORY AND CORRELATIVE OBJECTIVES:

I. To use the collected blood and tissue materials for exploratory analysis to identify markers that predict prognosis of biliary tree cancers.

II. To correlate the identified markers with results of specific aim I and II to test the interaction between the identified markers with environmental and genetic factors.

OUTLINE:

Participants complete a questionnaire over 20 minutes. Participants also undergo collection of blood and leftover tissue samples.

Study Type

Observational

Enrollment (Estimated)

1500

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 Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Manal M Hassan

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with biliary tree cancer and healthy participants

Description

Inclusion Criteria:

  • Pathologically or radiologically confirmed diagnosis of CGC or GBC
  • With or without prior radiation or chemotherapy
  • All United States of America (USA) and non USA residents
  • No age, gender, or racial restriction
  • Healthy control with no current or history of cancer
  • Healthy controls are USA and non USA residents
  • Healthy controls are matched to the cases in age (5 years), gender, and race
  • Healthy controls are friends and spouses of patients with other than gastro-intestinal (GI) cancers
  • Chronic Liver Disease (CLD) controls with no current or history of cancer
  • CLD controls are USA and non USA residents
  • CLD controls are frequency matched to CGC cases by age (5 years), gender, and race
  • CLD controls are patients are diagnosed with or without liver biopsy (core or fine needle aspiration)
  • CLD controls must not have evidence liver cancer diagnosis by computed tomography (CT) or magnetic resonance imaging (MRI)

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (biospecimen collection, questionnaire)
Participants complete a questionnaire over 20 minutes. Participants also undergo collection of blood and leftover tissue samples.
Other: Questionnaire Administration
Complete questionnaire
Procedure: Biospecimen Collection
Undergo collection of tissue, and blood
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant factors that may contribute to the etiology of biliary tree cancer
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Manal M Hassan, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

September 25, 2017

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0089
  • NCI-2021-10936 (Other Identifier: Clinical Trials Reporting Program (CTRP))

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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