Molecular Epidemiology of Biliary Tree Cancers

  • STATUS
    Recruiting
  • days left to enroll
    46
  • participants needed
    1500
  • sponsor
    M.D. Anderson Cancer Center
Updated on 17 March 2022
cancer

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.

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.

Details
Condition Cholangiocarcinoma, Malignant Digestive System Neoplasm
Treatment questionnaire administration, biospecimen collection
Clinical Study IdentifierNCT05179486
SponsorM.D. Anderson Cancer Center
Last Modified on17 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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