Clinical trial NCT05179486: Molecular Epidemiology of Biliary Tree Cancers
Official title: Molecular Epidemiology of Biliary Tree Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cholangiocarcinoma
Malignant Digestive System Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biliary tree cancer and healthy participants

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.

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.

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

Primary outcomes:
measure: Significant factors that may contribute to the etiology of biliary tree cancer
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Manal M Hassan
role: PRINCIPAL_INVESTIGATOR
References: