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OpenTrials
Recruiting

NCT Number: NCT05179486

Molecular Epidemiology of Biliary Tree Cancers

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Manal M Hassan

CONTACT

[email protected]

713-794-5452

Manal M Hassan

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of tissue, and blood

Other names: Biological Sample Collection, Biospecimen Collected

Questionnaire Administration

Other

Complete questionnaire

Primary outcomes

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

    Time frame: through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Manal M Hassan

CONTACT

[email protected]

713-794-5452

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2022
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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