Pancreatic CystsNCT00828048
International Registry for Intraductal Papillary Mucinous Neoplasma
An observational study of Pancreatic Cysts, run by Mayo Clinic at 1 site in United States.
Trial summary
A centralized web-based database will be used to track patients with IPMN lesions of the pancreas to study natural history and risk factors for malignant transformation in this multi-center study. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cysts
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to 1 Nov 2019
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care
Who may be able to join
- Suspected IPMN based on the consensus guidelines (7)
- Endoscopic ultrasound imaging at baseline examination
- Either surgical histology or clinical follow up with EUS, MRI, or CT scan for at least 1 year
- Cases previously collected that meet the above criteria will be allowed
Who cannot join
- Patients who do not meet the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
About this study
A centralized web-based database will be used to track patients with IPMN lesions of the pancreas to study natural history and risk factors for malignant transformation in this multi-center study.
Read the detailed description
Intraductal papillary mucinous neoplasms of the pancreas (IPMN) are increasingly recognized in clinical practice. They represent a unique clinicopathologic entity that is characterized by mucin production, cystic dilation of the pancreatic ducts, and intraductal papillary growth. The World Health Organization recognized IPMN as a distinct clinical entity in 1996. Recent literature suggests that up to 45% of IPMN are malignant and should be resected; however these data are based on larger, primarily symptomatic lesions. Several studies have been published in the recent literature reporting single-center experience with IPMN resections and observations with small numbers of patients. The natural history of these lesions and risk of malignancy is still vague. Consensus guidelines for management of IPMN were published in 2006, but noted the limited knowledge available in six areas: definition and classification, preoperative evaluation, indication for resection, method of resection, histological data on frozen section/positive margins and specimen processing, and finally, method of follow-up. Speaking to this need, we propose an international registry for multi-center collaboration in the above areas of need in IPMN research and clinical management. This will be through a centralized, web-based registry with data entered by each center in a de-identified way to protect confidentiality.
The data collected from the IRB approved retrospective chart review IRB# 07-007202 will be incorporated into this data base. Any patients that participate in the prospective study will be consented with HIPPA consent prior to collection of data.
- Conditions
- Pancreatic Cysts
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cyst | Pancreatic Cyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify clinical and morphological predictors of cancer or high grade dysplasia in patients with IPMN. Identify predictors of progression to cancer or high grade dysplasia among patients who are followed in surveillance programs.
Size and growth pattern of pancreas cysts, presence of mural nodules, development of solid tumor or malignancy will be tracked over time, based on imaging studies including EUS, MRI or CT as clinically indicated.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startMar 2008
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
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 Mayo ClinicThe 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
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele D. Lewis, M.D., Mayo Clinic
- Investigators
- Michele D Lewis, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828048
- Sponsor's protocol ID
- 07-007845
- Status last verified
- Nov 2019
- First submitted
- 21 Jan 2009
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry for Intraductal Papillary Mucinous Neoplasma
- ClinicalTrials.gov ID
- NCT00828048
- Acronym / sponsor ID
- 07-007845
- Conditions
- Pancreatic Cysts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 23 Jan 2009 (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.
A centralized web-based database will be used to track patients with IPMN lesions of the pancreas to study natural history and risk factors for malignant transformation in this multi-center study.
Detailed description
Intraductal papillary mucinous neoplasms of the pancreas (IPMN) are increasingly recognized in clinical practice. They represent a unique clinicopathologic entity that is characterized by mucin production, cystic dilation of the pancreatic ducts, and intraductal papillary growth. The World Health Organization recognized IPMN as a distinct clinical entity in 1996. Recent literature suggests that up to 45% of IPMN are malignant and should be resected; however these data are based on larger, primarily symptomatic lesions. Several studies have been published in the recent literature reporting single-center experience with IPMN resections and observations with small numbers of patients. The natural history of these lesions and risk of malignancy is still vague. Consensus guidelines for management of IPMN were published in 2006, but noted the limited knowledge available in six areas: definition and classification, preoperative evaluation, indication for resection, method of resection, histological data on frozen section/positive margins and specimen processing, and finally, method of follow-up. Speaking to this need, we propose an international registry for multi-center collaboration in the above areas of need in IPMN research and clinical management. This will be through a centralized, web-based registry with data entered by each center in a de-identified way to protect confidentiality.
The data collected from the IRB approved retrospective chart review IRB# 07-007202 will be incorporated into this data base. Any patients that participate in the prospective study will be consented with HIPPA consent prior to collection of data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cyst | – | –Pancreatic Cyst |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care
Key inclusion criteria (4 listed)
- Suspected IPMN based on the consensus guidelines (7)
- Endoscopic ultrasound imaging at baseline examination
- Either surgical histology or clinical follow up with EUS, MRI, or CT scan for at least 1 year
- Cases previously collected that meet the above criteria will be allowed
Key exclusion criteria (1 listed)
- Patients who do not meet the above inclusion criteria
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
Identify clinical and morphological predictors of cancer or high grade dysplasia in patients with IPMN. Identify predictors of progression to cancer or high grade dysplasia among patients who are followed in surveillance programs.
Time frame: End of study
Size and growth pattern of pancreas cysts, presence of mural nodules, development of solid tumor or malignancy will be tracked over time, based on imaging studies including EUS, MRI or CT as clinically indicated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michele D Lewis, MD principal investigator
Mayo Clinic
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 Mayo Clinic 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 4 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: finished, as of the sponsor's last update on 6 Nov 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identify clinical and morphological predictors of cancer or high grade dysplasia in patients with IPMN. Identify predictors of progression to cancer or high grade dysplasia among patients who are followed in surveillance programs. (time frame: End of study). 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 6 Nov 2019.