Molecular Epidemiology of Biliary Tree Cancers

Cholangiocarcinoma Clinical Trial

Official title:

Molecular Epidemiology of Biliary Tree Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179486
• Other study ID #: 2017-0089
• Status: Recruiting
• Start date: September 25, 2017
• Est. completion date: February 2, 2027

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Manal M Hassan
• Phone: 713-794-5452
• Email: mhassan[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Malignant Digestive System Neoplasm

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of tissue, and blood

Other:
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant factors that may contribute to the etiology of biliary tree cancer		through study completion, an average of 1 year

External Links

•   M D Anderson Cancer Center website