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Molecular Epidemiology of Biliary Tree Cancers

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05179486
Collaborator
(none)
1,500
Enrollment
1
Location
60.2
Anticipated Duration (Months)
24.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

  1. To identify significant factors that may contribute to the etiology of biliary tree cancer.

  2. To identify novel genetic loci that predispose to gallbladder cancers (GBC) and cholangiocarcinoma (CGC) diagnosis.

EXPLORATORY AND CORRELATIVE OBJECTIVES:

  1. To use the collected blood and tissue materials for exploratory analysis to identify markers that predict prognosis of biliary tree cancers.

  2. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Molecular Epidemiology of Biliary Tree Cancers
Actual Study Start Date :
Sep 25, 2017
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Observational (biospecimen collection, questionnaire)

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

Procedure: Biospecimen Collection
Undergo collection of tissue, and blood
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected

    • Other: Questionnaire Administration
    Complete questionnaire

    Outcome Measures

    Primary Outcome Measures

    1. Significant factors that may contribute to the etiology of biliary tree cancer [through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Manal M Hassan, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05179486
    Other Study ID Numbers:
    • 2017-0089
    First Posted:
    Jan 5, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cholangiocarcinoma
    Digestive System Neoplasms
    Gastrointestinal Neoplasms

    Study Results

    No Results Posted as of Aug 22, 2022