Pancreatic CystsNCT02110498
Early Detection of Pancreatic Cystic Neoplasms
An observational study of Pancreatic Cysts and Intraductal Papillary Mucinous Neoplasm, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to learn more about pancreatic cysts. The tests that are currently available are imperfect at determining exactly what type of pancreatic cyst a person has, which cysts contain cancer, or what the risk is of developing cancer in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cysts, Intraductal Papillary Mucinous Neoplasm, Pancreatic Mucinous-Cystic Neoplasm
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2025
- 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: Any individual with a pancreatic cyst seen at the Johns Hopkins Hospital or other participating Institutions.
Who may be able to join
- Adult patients age 18 years and older with pancreatic cyst.
Who cannot join
- Individuals with ASA class 4 or greater.
- Inability to provide informed consent.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
This research is being done to learn more about pancreatic cysts. The tests that are currently available are imperfect at determining exactly what type of pancreatic cyst a person has, which cysts contain cancer, or what the risk is of developing cancer in the future. The aim of this study is to use a combination of clinical, imaging, cyst fluid analysis, and molecular markers to try to help develop better tools to answer these questions.
Read the detailed description
Incidental pancreatic cysts are increasingly recognized due to the widespread use of cross-sectional imaging techniques such as CT and MRI. A number of lesions in the pancreas can form cysts, including serous cystadenomas (SCA), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), solid-pseudopapillary neoplasms (SPNs), and pseudocysts. SCAs and pseudocysts are considered benign; whereas SPNs are considered malignant and require surgical resection. IPMNs and MCNs are considered neoplasms with malignant potential, although the exact risk of malignant progression of these cysts is unknown. Currently, MCN are all surgically resected, whereas IPMN are resected if they have features suspicious for malignancy.
However, current diagnostic tests cannot always reliably distinguish harmless from potentially harmful cysts. Recent studies conducted at Johns Hopkins have shown that each cyst type has unique genetic features that could be used as diagnostic biomarkers. In this study, clinical, imaging data and cyst fluid analysis of individuals with pancreatic cysts will be collected. In patients who undergo an endoscopic ultrasound (EUS) procedure, if a fine needle aspiration (EUS-FNA) is performed, and there is extra cyst fluid left after standard clinical tests have been sent, the extra cyst fluid will be submitted for molecular marker analysis. If an individual undergoes surgery to remove the cyst, cyst fluid will be collected after the cyst has been removed. In addition, a small amount of blood will be collected at the time of the EUS or surgical procedure.
AIMS: The general aim is to propose and prospectively validate a diagnostic approach and model for prediction of mucinous versus non-mucinous, and malignant versus non-malignant, pancreatic cysts using a combination of clinical, radiologic, and biomarker characteristics.
- Conditions
- Pancreatic Cysts, Intraductal Papillary Mucinous Neoplasm, Pancreatic Mucinous-Cystic Neoplasm, Cystic, Mucinous and/or Serous Neoplasm, Solid Pseudopapillary Tumour of the Pancreas
- Keywords
- Pancreatic cyst, IPMN, SCA, SPN, MCN, pancreatic cystic neoplasm
- Medical subject headings
- Pancreatic Cyst
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop and prospectively validate a panel of molecular markers to differentiate benign pancreatic cysts from those with malignant potential using surgical pathology as the gold standard
Measured: 3 years
Secondary outcomes (1)
To determine the sensitivity, specificity, and overall accuracy of imaging (CT, MRI and EUS) in patients with pancreatic cysts
Sensitivity and specificity of imaging results in identifying malignant and mucinous cysts will be calculated using the pathology result as the reference gold standard. The overall accuracy of the imaging results, defined as percent agreement with pathology, will also be calculated. Estimates will be reported with exact binomial 95% confidence intervals.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2025
- Study completionMar 2025
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 Johns Hopkins 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Lustgarten Foundation
- Responsible party
- Sponsor
- Investigators
- Anne Marie O'Broin-Lennon, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110498
- Sponsor's protocol ID
- NA_00084662
- Status last verified
- Feb 2026
- First submitted
- 30 Mar 2014
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Pancreatic Cystic Neoplasms
- ClinicalTrials.gov ID
- NCT02110498
- Acronym / sponsor ID
- NA_00084662
- Conditions
- Pancreatic Cysts, Intraductal Papillary Mucinous Neoplasm, Pancreatic Mucinous-Cystic Neoplasm, Cystic, Mucinous and/or Serous Neoplasm, Solid Pseudopapillary Tumour of the Pancreas
- Keywords
- Pancreatic cyst, IPMN, SCA, SPN, MCN, pancreatic cystic neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Lustgarten Foundation
- Study start
- Mar 2014
- Primary completion
- Mar 2025 (actual)
- Study completion
- Mar 2025 (actual)
- First posted
- 10 Apr 2014 (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.
This research is being done to learn more about pancreatic cysts. The tests that are currently available are imperfect at determining exactly what type of pancreatic cyst a person has, which cysts contain cancer, or what the risk is of developing cancer in the future. The aim of this study is to use a combination of clinical, imaging, cyst fluid analysis, and molecular markers to try to help develop better tools to answer these questions.
Detailed description
Incidental pancreatic cysts are increasingly recognized due to the widespread use of cross-sectional imaging techniques such as CT and MRI. A number of lesions in the pancreas can form cysts, including serous cystadenomas (SCA), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), solid-pseudopapillary neoplasms (SPNs), and pseudocysts. SCAs and pseudocysts are considered benign; whereas SPNs are considered malignant and require surgical resection. IPMNs and MCNs are considered neoplasms with malignant potential, although the exact risk of malignant progression of these cysts is unknown. Currently, MCN are all surgically resected, whereas IPMN are resected if they have features suspicious for malignancy.
However, current diagnostic tests cannot always reliably distinguish harmless from potentially harmful cysts. Recent studies conducted at Johns Hopkins have shown that each cyst type has unique genetic features that could be used as diagnostic biomarkers. In this study, clinical, imaging data and cyst fluid analysis of individuals with pancreatic cysts will be collected. In patients who undergo an endoscopic ultrasound (EUS) procedure, if a fine needle aspiration (EUS-FNA) is performed, and there is extra cyst fluid left after standard clinical tests have been sent, the extra cyst fluid will be submitted for molecular marker analysis. If an individual undergoes surgery to remove the cyst, cyst fluid will be collected after the cyst has been removed. In addition, a small amount of blood will be collected at the time of the EUS or surgical procedure.
AIMS: The general aim is to propose and prospectively validate a diagnostic approach and model for prediction of mucinous versus non-mucinous, and malignant versus non-malignant, pancreatic cysts using a combination of clinical, radiologic, and biomarker characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any individual with a pancreatic cyst seen at the Johns Hopkins Hospital or other participating Institutions.
Key inclusion criteria (1 listed)
- Adult patients age 18 years and older with pancreatic cyst.
Key exclusion criteria (3 listed)
- Individuals with ASA class 4 or greater.
- Inability to provide informed consent.
- Pregnancy or lactation.
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 develop and prospectively validate a panel of molecular markers to differentiate benign pancreatic cysts from those with malignant potential using surgical pathology as the gold standard
Time frame: 3 years
1 secondary outcome
To determine the sensitivity, specificity, and overall accuracy of imaging (CT, MRI and EUS) in patients with pancreatic cysts
Time frame: 3 years
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 2 Mar 2026.
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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.
Anne Marie O'Broin-Lennon, MD, PhD principal investigator
Johns Hopkins 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 Pancreatic Cysts and Intraductal Papillary Mucinous Neoplasm, run by Johns Hopkins 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 3 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 2 Mar 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?
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?
To develop and prospectively validate a panel of molecular markers to differentiate benign pancreatic cysts from those with malignant potential using surgical pathology as the gold standard (time frame: 3 years). 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 2 Mar 2026.