Molecular Epidemiology of Biliary Tree Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Cholangiocarcinoma, Malignant Digestive System Neoplasm. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of tissue, and blood - Other Questionnaire Administration
Complete questionnaire
Primary outcome measures
- Significant factors that may contribute to the etiology of biliary tree cancer [Time frame: through study completion, an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05179486 · 2017-0089 · NCI-2021-10936