Molecular Epidemiology of Biliary Tree Cancers | NCT05179486

Studies
Molecular Epidemiology of Biliary Tree Cancers

NCT05179486

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

Apr 17, 2026Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Cholangiocarcinoma
Malignant Digestive System Neoplasm

Interventions

Biospecimen Collection
Questionnaire Administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2021-10936	Other Identifier	Clinical Trials Reporting Program (CTRP)

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2017Actual

Primary Completion Date

Feb 2, 2027Estimated

Completion Date

Feb 2, 2027Estimated

First Submitted Date

Dec 13, 2021

First Submission Date that Met QC Criteria

Dec 29, 2021

First Posted Date

Jan 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2026

Last Update Posted Date

Apr 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational (biospecimen collection, questionnaire)		Participants complete a questionnaire over 20 minutes. Participants also undergo collection of blood and leftover tissue samples.	Procedure: Biospecimen Collection Other: Questionnaire Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biospecimen Collection	Procedure	Undergo collection of tissue, and blood	Observational (biospecimen collection, questionnaire)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Significant factors that may contribute to the etiology of biliary tree cancer		through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with biliary tree cancer and healthy participants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manal M Hassan	Contact	713-794-5452		mhassan@mdanderson.org

Overall Officials

Name	Affiliation	Role
Manal M Hassan	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States

Label	URL
M D Anderson Cancer Center website	View source

Condition Browse Module

MeSH Terms

ID	Term
D018281	Cholangiocarcinoma
D005770	Gastrointestinal Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

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Browse Branches

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