CholangiocarcinomaNCT05179486
Molecular Epidemiology of Biliary Tree Cancers
An observational study of Cholangiocarcinoma and Malignant Digestive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholangiocarcinoma, Malignant Digestive System Neoplasm
- What is being tested?
- Biospecimen Collection and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 2 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with biliary tree cancer and healthy participants
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Manal M Hassan, 713-794-5452, mhassan@mdanderson.org
Manal M Hassan
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Biospecimen Collection, Questionnaire Administration
- Medical subject headings
- Cholangiocarcinoma, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected
Undergo collection of tissue, and blood
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Observational (biospecimen collection, questionnaire) | Participants complete a questionnaire over 20 minutes. Participants also undergo collection of blood and leftover tissue samples. Receives: Procedure: Biospecimen Collection; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant factors that may contribute to the etiology of biliary tree cancer
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start25 Sep 2017
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manal M Hassan, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179486
- Sponsor's protocol ID
- 2017-0089
- Other IDs
- NCI-2021-10936
- Status last verified
- Apr 2026
- First submitted
- 13 Dec 2021
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Epidemiology of Biliary Tree Cancers
- ClinicalTrials.gov ID
- NCT05179486
- Acronym / sponsor ID
- 2017-0089
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen collection, questionnaire) | – | Procedure: Biospecimen Collection, Other: Questionnaire AdministrationParticipants complete a questionnaire over 20 minutes. Participants also undergo collection of blood and leftover tissue samples. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with biliary tree cancer and healthy participants
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen CollectedUndergo collection of tissue, and blood | Procedure or surgery | Observational (biospecimen collection, questionnaire) |
| Questionnaire AdministrationComplete questionnaire | Other | Observational (biospecimen collection, questionnaire) |
Primary outcome
Significant factors that may contribute to the etiology of biliary tree cancer
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- M D Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manal M Hassan principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma and Malignant Digestive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manal M Hassan (713-794-5452, mhassan@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.