Molecular Epidemiology of Biliary Tree Cancers

NCT05179486 | Recruiting

• 2 other identifiers: 2017-0089NCI-2021-10936
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholangiocarcinoma; Malignant Digestive System Neoplasm

Outcome Measures

Primary Outcomes (1)

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

  through study completion, an average of 1 year

Study Arms (1)

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

Biospecimen Collection PROCEDURE

Undergo collection of tissue, and blood

Also known as: Biological Sample Collection, Biospecimen Collected

Observational (biospecimen collection, questionnaire)

Questionnaire Administration OTHER

Complete questionnaire

Observational (biospecimen collection, questionnaire)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with biliary tree cancer and healthy participants

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center website

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Conditions

Cholangiocarcinoma; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Manal M Hassan

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manal M Hassan

CONTACT

713-794-5452; mhassan@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 5, 2022
• Study Start: September 25, 2017
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)