Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05179486

Conditions

Cholangiocarcinoma

Malignant Digestive System Neoplasm

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Questionnaire Administration

Study Details

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.

Conditions

Cholangiocarcinoma

Malignant Digestive System Neoplasm

Study ID

NCT05179486

Start date

Sep 25, 2017

Status verified date

Apr, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (biospecimen collection, questionnaire)

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

Interventions

Biospecimen Collection

Undergo collection of tissue, and blood

Questionnaire Administration

Complete questionnaire

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Manal M Hassan

713-794-5452mhassan@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Manal M Hassan

713-794-5452mhassan@mdanderson.org

Principal Investigator:

Manal M Hassan

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-17.