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RecruitingNCT05179486Updated Apr 17, 2026

Molecular Epidemiology of Biliary Tree Cancers

An observational study in Cholangiocarcinoma and Malignant Digestive System Neoplasm, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by M.D. Anderson Cancer Center · Observational

From the registry’s dates

  • Started Sep 2017; still recruiting 9 years later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,500
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Cholangiocarcinoma
  • Malignant Digestive System Neoplasm
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In context

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 196 across 176 observational studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with biliary tree cancer and healthy participants

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

Exclusion Criteria:

  • None
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational (biospecimen collection, questionnaire)

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

    Procedure: Biospecimen Collection · Other: Questionnaire Administration

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of tissue, and blood

    Also known as: Biological Sample Collection, Biospecimen Collected

  • OtherQuestionnaire Administration

    Complete questionnaire

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What researchers measure

Primary outcomes

  1. Significant factors that may contribute to the etiology of biliary tree cancer

    Time frame: through study completion, an average of 1 year

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Study locations

1 of 1 sites recruiting
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05179486
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jan 5, 2022
Start date
Sep 25, 2017
Primary completion
Feb 2, 2027 (estimated)
Completion
Feb 2, 2027 (estimated)
Last update
Apr 17, 2026

Study contacts

Manal M Hassan
Contact
mhassan@mdanderson.org
713-794-5452
Manal M Hassan
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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