Pancreatic CystsNCT01769534
Registry and Fluid Banking of Pancreatic Cystic Lesions
An observational study of Pancreatic Cysts, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to follow patients, who have small mucinous cysts in the pancreas, prospectively over a 5-year period. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cysts
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2016
- How long will I take part?
- 5 Years
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s).
Who may be able to join
- consented patients between age 18 to 85 who are referred for EUS evaluation of pancreatic cysts.
Who cannot join
- Patient unable to give informed consent
- age<18 or >85, patients with clinically suspected pseudocysts.
Trial locations and contacts
1 site in 1 country.
United States1 site
Endoscopy Centrer at OU Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Prospective Registry and Cystic Fluid Banking for Patients Undergoing EUS-FNA for the Evaluation of Pancreatic Cystic Lesions.
The purpose of this study is to follow patients, who have small mucinous cysts in the pancreas, prospectively over a 5-year period.
Read the detailed description
The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s). At that time, we will recruit them to be in the patient registry and tissue repository. Their enrollment in the patient registry will allow us to contact them annually for survey purposes. Their enrollment in the tissue repository will allow us to store left-over pancreatic cyst fluid that was already aspirated for analysis (as part of the standard-of-care workup for pancreatic cysts).
- Conditions
- Pancreatic Cysts
- Medical subject headings
- Pancreatic Cyst
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the Sendai criteria prospectively in patients with pancreatic cysts.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Administratively inactivated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CystsStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John T Maple, M.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769534
- Sponsor's protocol ID
- 2487
- Status last verified
- Dec 2017
- First submitted
- 14 Jan 2013
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry and Cystic Fluid Banking for Patients Undergoing EUS-FNA for the Evaluation of Pancreatic Cystic Lesions.
- ClinicalTrials.gov ID
- NCT01769534
- Acronym / sponsor ID
- 2487
- Conditions
- Pancreatic Cysts
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Administratively inactivated
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Jan 2013 (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 this study is to follow patients, who have small mucinous cysts in the pancreas, prospectively over a 5-year period.
Detailed description
The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s). At that time, we will recruit them to be in the patient registry and tissue repository. Their enrollment in the patient registry will allow us to contact them annually for survey purposes. Their enrollment in the tissue repository will allow us to store left-over pancreatic cyst fluid that was already aspirated for analysis (as part of the standard-of-care workup for pancreatic cysts).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s).
Key inclusion criteria (1 listed)
- consented patients between age 18 to 85 who are referred for EUS evaluation of pancreatic cysts.
Key exclusion criteria (2 listed)
- Patient unable to give informed consent
- age<18 or >85, patients with clinically suspected pseudocysts.
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
To validate the Sendai criteria prospectively in patients with pancreatic cysts.
Time frame: up to 1 year
Results and safety
The study was stopped early (reason given: Administratively inactivated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
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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.
John T Maple, M.D. principal investigator
University of Oklahoma
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 Pancreatic Cysts, run by University of Oklahoma 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 2 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 19 Dec 2017. 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: Administratively inactivated). 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?
To validate the Sendai criteria prospectively in patients with pancreatic cysts. (time frame: up to 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 19 Dec 2017.