Understanding risk factors and genetic changes in biliary tree cancers
Official title: Molecular Epidemiology of Biliary Tree Cancers
Run by M.D. Anderson Cancer Center · NCT05179486 · Data updated 2026-11-12
This study is trying to find out what causes biliary tree cancers and how genetic changes can help doctors understand treatment responses in patients with these cancers.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | September 25, 2017 |
| Main results expected | February 2, 2027 |
| Study ends | February 2, 2027 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT05179486 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with a confirmed diagnosis of cholangiocarcinoma or gallbladder cancer, as well as healthy controls and patients with chronic liver disease.
✕Probably not a fit
Patients without a diagnosis of biliary tree cancers or chronic liver disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify risk factors, tumor markers, and genetic changes that may predict the development and outcomes of biliary tree cancers, specifically cholangiocarcinoma and gallbladder cancer. Participants will complete a questionnaire and provide blood and tissue samples for analysis. The study seeks to establish biomarker models that can help doctors understand how different treatments affect biliary tree cancer and why responses vary among patients.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of cancer outcomes and more personalized treatment strategies for patients with biliary tree cancers.
How similar studies have gone: Other studies have shown success in identifying genetic and environmental factors related to cancer, making this approach promising but not entirely novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
M D Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Manal M Hassan — M.D. Anderson Cancer Center
- Study coordinator: Manal M Hassan
- Email: mhassan@mdanderson.org
- Phone: 713-794-5452
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.