Gallbladder CancerNCT00414843
Storage of Bile From Routine Procedures to Study Risk Factors
An observational study of Gallbladder Cancer and Cholangiocarcinoma, run by Indiana University at 1 site in United States.
Trial summary
The purpose of the study is to establish a repository of human bile as a resource for studies evaluating molecular predictors of biliary cancer risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Cancer, Cholangiocarcinoma, Biliary Tract Cancer
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects presenting to Indiana University for treatment of biliary tract disease.
Who may be able to join
- Presenting to IU for treatment of biliary tract disease; Age greater than or equal to 18
Who cannot join
- Problems other than biliary tract disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: A Prospective Study of Human Bile and Molecular Predictors of Biliary Malignancy Risk
The purpose of the study is to establish a repository of human bile as a resource for studies evaluating molecular predictors of biliary cancer risk.
Read the detailed description
The specific aim of this study is to establish a repository of human bile to serve as a resource for studies looking at molecular predictors of biliary tract cancer. The development of fluid based biomarkers will enable early diagnosis in at-risk individuals with a recognized risk factor for cholangiocarcinoma, as well as provide surveillance mechanisms for screening populations where biliary tract cancer has a high incidence.
- Conditions
- Gallbladder Cancer, Cholangiocarcinoma, Biliary Tract Cancer
- Keywords
- Storage, Bile, Biomarkers, biliary malignancies
- Medical subject headings
- Gallbladder Neoplasms, Cholangiocarcinoma, Biliary Tract Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish Repository of Human Bile
Establish a repository of human bile that will serve as a resource through which studies can be performed looking at molecular predictors of biliary tract cancer risk.
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Decreasing interest in using samples; department infrastructure waned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Maluccio, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414843
- Sponsor's protocol ID
- 0611-55
- Other IDs
- IUCRO-0176
- Status last verified
- Feb 2016
- First submitted
- 21 Dec 2006
- Last updated
- 23 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Human Bile and Molecular Predictors of Biliary Malignancy Risk
- ClinicalTrials.gov ID
- NCT00414843
- Acronym / sponsor ID
- 0611-55
- Conditions
- Gallbladder Cancer, Cholangiocarcinoma, Biliary Tract Cancer
- Keywords
- Storage, Bile, Biomarkers, biliary malignancies
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decreasing interest in using samples; department infrastructure waned
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Dec 2006 (estimated)
- 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.
The purpose of the study is to establish a repository of human bile as a resource for studies evaluating molecular predictors of biliary cancer risk.
Detailed description
The specific aim of this study is to establish a repository of human bile to serve as a resource for studies looking at molecular predictors of biliary tract cancer. The development of fluid based biomarkers will enable early diagnosis in at-risk individuals with a recognized risk factor for cholangiocarcinoma, as well as provide surveillance mechanisms for screening populations where biliary tract cancer has a high incidence.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting to Indiana University for treatment of biliary tract disease.
Key inclusion criteria (1 listed)
- Presenting to IU for treatment of biliary tract disease; Age greater than or equal to 18
Key exclusion criteria (1 listed)
- Problems other than biliary tract disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish Repository of Human Bile
Time frame: 2024
Establish a repository of human bile that will serve as a resource through which studies can be performed looking at molecular predictors of biliary tract cancer risk.
Results and safety
The study was stopped early (reason given: Decreasing interest in using samples; department infrastructure waned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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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. This study is not recruiting at the moment.
Mary Maluccio, MD principal investigator
Indiana University
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 Gallbladder Cancer and Cholangiocarcinoma, run by Indiana University 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 1 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: stopped early, as of the sponsor's last update on 23 Feb 2016. 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?
The study was stopped early (reason given: Decreasing interest in using samples; department infrastructure waned). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish Repository of Human Bile (time frame: 2024). 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 23 Feb 2016.