Molecular Epidemiology of Biliary Tree Cancers

Recruiting

• Conditions: Cholangiocarcinoma; Malignant Digestive System Neoplasm
• Interventions: Procedure: Biospecimen Collection; Other: Questionnaire Administration

• Registration Number: NCT05179486
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-25
• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2027-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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)

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (biospecimen collection, questionnaire)	Questionnaire Administration	Participants complete a questionnaire over 20 minutes. Participants also undergo collection of blood and leftover tissue samples.
Observational (biospecimen collection, questionnaire)	Biospecimen Collection	Participants complete a questionnaire over 20 minutes. Participants also undergo collection of blood and leftover tissue samples.

Primary Outcome Measures

Name	Time	Method
Significant factors that may contribute to the etiology of biliary tree cancer	through study completion, an average of 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States