Molecular Epidemiology of Biliary Tree Cancers

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Malignant Digestive System Neoplasm

Cholangiocarcinoma

Treatments

Procedure: Biospecimen Collection

Other: Questionnaire Administration

Study type

Observational

Funder types

Other

Identifiers

NCT05179486

2017-0089

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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)