Molecular Epidemiology of Biliary Tree Cancers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-25

Study Completion Date

2027-02-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cholangiocarcinoma Malignant Digestive System Neoplasm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (biospecimen collection, questionnaire)

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

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of tissue, and blood

Questionnaire Administration

Intervention Type OTHER

Complete questionnaire

Interventions

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Biospecimen Collection

Undergo collection of tissue, and blood

Intervention Type PROCEDURE

Questionnaire Administration

Complete questionnaire

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected

Eligibility Criteria

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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)