Pancreatic CystsPCystNCT01202136
The Clinical,Radiologic,Pathologic and Molecular Marker Characteristics of Pancreatic Cysts Study
An observational study of Pancreatic Cysts and Pancreatic Cancer, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cysts, Pancreatic Cancer
- How many people
- 477 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred to Johns Hopkins for evaluation of pancreatic cysts
Who may be able to join
- Adult patients age 18 years and older
- Referred for assessment of one or more pancreatic cyst.
Who cannot join
- Medically ill patients with ASA class 4 or greater.
- History of chronic kidney disease with a serum creatinine > 2.0 mg/dl or estimated glomerulofiltration rate (eGFR) < 30 ml/min, dialysis patients, acute renal failure, cirrhosis of the liver, chronic hepatitis, prior nephrectomy or kidney or liver transplantation.
- History of moderate (generalized hives) or severe (facial swelling, airway reaction) reaction to intravenous radiographic contrast material.
- History of obstruction in the upper GI tract such as esophageal or pyloric stricture, which would not allow passage of an endoscope.
- Bleeding diathesis (clotting problems) or a history of thrombocytopenia (low platelet count <50,000).
- Inability to provide informed consent.
- Pregnancy or lactation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21231
Johns Hopkins Medicine
Baltimore, Maryland, 21287
About this study
Official title: The Clinical,Radiologic, Pathologic and Molecular Marker Characteristics of Premalignant and Malignant Pancreatic Cysts Study
The 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.
Read the detailed description
This combined cross-sectional and prospective single center clinical and translational study involves a collaborative multidisciplinary team composed of gastroenterologists, surgeons, radiologists, and basic scientists. Eligible patients with solitary or multiple pancreatic cysts referred for diagnostic evaluation and/or surgical treatment will undergo initial radiographic imaging with high-resolution CT, MRI/MRCP, and EUS/FNA as part of standard medical care at Johns Hopkins Hospital. This is a three-phase study.
In Phase I, eligible patients with pancreatic cysts will undergo initial radiographic imaging (high-resolution CT, MRI/MRCP, endoscopic ultrasonography (EUS) with fine needle aspiration (FNA)) as part of standard care at the Johns Hopkins Hospital. Patients will be categorized according to the presence of symptoms referable to the cyst or imaging features concerning for malignancy based on the initial radiographic assessment. Symptomatic patients, or those with concerning features, will be referred for surgical resection. The pathologic features and final diagnosis of resected pancreatic cysts will be compared with preoperative clinical, radiologic, and cyst fluid test results.
Asymptomatic patients with low-risk features at baseline radiographic and endoscopic imaging will enter Phase II. Patients will be followed on a prospective periodic surveillance schedule according the consensus clinical guidelines with either CT or MRI to monitor for new or metachronous cystic neoplasms. Those who develop symptoms or concerning features will have a repeat EUS/FNA as well as imaging with the opposite axial imaging modality, and will be referred for surgery if a suspicious lesion is detected.
Patients who have surgery either during Phase I or Phase II, will enter post-surgical surveillance (Phase III). Patients will be followed using a prospective periodic surveillance schedule according the consensus clinical guidelines with either CT or MRI to monitor for new or metachronous cystic neoplasms. Those who undergo surgery after surveillance in Phase II will continue with the imaging modality they were originally evaluated with prior to surgery.. Patients who develop symptoms or high-risk features on imaging will have a repeat EUS/FNA as well as imaging with the opposite axial imaging modality and will be referred for surgery if a suspicious lesion is detected. Samples will be collected prospectively for biomarker analysis. Cyst fluid, pancreatic juice and blood will be collected during EUS and blood will be collected yearly during the outpatient clinic visit. Patients will be followed for three years.
- Conditions
- Pancreatic Cysts, Pancreatic Cancer
- Keywords
- pancreatic cyst, IPMN, PAN INs, Pancreatic cancer, pancreatic neoplasia
- Medical subject headings
- Pancreatic Cyst, Pancreatic Neoplasms
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 cysts | patients referred to Johns Hopkins Hospital for evaluation and or treatment for 1 or more pancreatic cysts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and incidence of malignant pancreatic cysts
1)to determine the prevalence and incidence of malignancy in pancreatic cysts according to cyst size and concerning features
Measured: 3-6 years
Secondary outcomes (6)
Biomarkers to predict type of pancreatic cyst
To collect tissue samples (cyst fluid and blood) for research on molecular markers in pancreatic cysts
Measured: 3-6 years
Biomarker panel in pancreatic juice as indicator to type of pancreatic cyst
To develop a panel of candidate biomarkers in pancreatic juice and serum as indicators of prevalent and incident malignancy in patients with surgically-proven neoplastic pancreatic cysts compared to non-neoplastic cysts (pseudocysts, lymphoepithelial cysts, congenital cysts)
Measured: 3-6 years
Compare CT with EUS and MRI for diagnosing pancreatic cysts.
to determine the sensitivity, specificity, and overall accuracy of pancreatic protocol CT, EUS, and/or MRCP in patients with pancreatic cysts, using surgical pathology as the reference standard
Measured: 3-6 year
Difference EUS/CT or MRCP in diagnosis of malignant pancreatic cysts
to calculate difference in diagnostic accuracy and clinical impact (change in preoperative diagnosis and treatment plan) of additional diagnostic tests (EUS and/or MRCP) over pancreatic protocol CT for the diagnosis of neoplastic/malignant pancreatic cysts.
Measured: 3-6 years
Associated factors for with multivariate model for malignant pancreatic cyst
to determine the factors associated with prevalent and incident malignancy in pancreatic cyst using a multivariate model including clinical, radiologic, and molecular markers
Measured: 3-6 years
Model for prediction of malignant pancreatic cysts
to determine the best model for prediction of malignancy in pancreatic cysts using multiple logistic regression and discriminant function analysis, including clinical, radiologic, and molecular markers
Measured: 3-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startOct 2012
- Primary completionJan 2019
- Study completionSep 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 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
- 477 participants (actual)
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, Principal investigator, John Hopkins University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202136
- Sponsor's protocol ID
- NA_00026447
- Acronym
- PCyst
- Status last verified
- Feb 2026
- First submitted
- 9 Sep 2010
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical,Radiologic, Pathologic and Molecular Marker Characteristics of Premalignant and Malignant Pancreatic Cysts Study
- ClinicalTrials.gov ID
- NCT01202136
- Acronym / sponsor ID
- PCyst / NA_00026447
- Conditions
- Pancreatic Cysts, Pancreatic Cancer
- Keywords
- pancreatic cyst, IPMN, PAN INs, Pancreatic cancer, pancreatic neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Lustgarten Foundation
- Study start
- Oct 2012
- Primary completion
- Jan 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 15 Sep 2010 (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 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.
Detailed description
This combined cross-sectional and prospective single center clinical and translational study involves a collaborative multidisciplinary team composed of gastroenterologists, surgeons, radiologists, and basic scientists. Eligible patients with solitary or multiple pancreatic cysts referred for diagnostic evaluation and/or surgical treatment will undergo initial radiographic imaging with high-resolution CT, MRI/MRCP, and EUS/FNA as part of standard medical care at Johns Hopkins Hospital. This is a three-phase study.
In Phase I, eligible patients with pancreatic cysts will undergo initial radiographic imaging (high-resolution CT, MRI/MRCP, endoscopic ultrasonography (EUS) with fine needle aspiration (FNA)) as part of standard care at the Johns Hopkins Hospital. Patients will be categorized according to the presence of symptoms referable to the cyst or imaging features concerning for malignancy based on the initial radiographic assessment. Symptomatic patients, or those with concerning features, will be referred for surgical resection. The pathologic features and final diagnosis of resected pancreatic cysts will be compared with preoperative clinical, radiologic, and cyst fluid test results.
Asymptomatic patients with low-risk features at baseline radiographic and endoscopic imaging will enter Phase II. Patients will be followed on a prospective periodic surveillance schedule according the consensus clinical guidelines with either CT or MRI to monitor for new or metachronous cystic neoplasms. Those who develop symptoms or concerning features will have a repeat EUS/FNA as well as imaging with the opposite axial imaging modality, and will be referred for surgery if a suspicious lesion is detected.
Patients who have surgery either during Phase I or Phase II, will enter post-surgical surveillance (Phase III). Patients will be followed using a prospective periodic surveillance schedule according the consensus clinical guidelines with either CT or MRI to monitor for new or metachronous cystic neoplasms. Those who undergo surgery after surveillance in Phase II will continue with the imaging modality they were originally evaluated with prior to surgery.. Patients who develop symptoms or high-risk features on imaging will have a repeat EUS/FNA as well as imaging with the opposite axial imaging modality and will be referred for surgery if a suspicious lesion is detected. Samples will be collected prospectively for biomarker analysis. Cyst fluid, pancreatic juice and blood will be collected during EUS and blood will be collected yearly during the outpatient clinic visit. Patients will be followed for three years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cysts | – | –patients referred to Johns Hopkins Hospital for evaluation and or treatment for 1 or more pancreatic cysts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to Johns Hopkins for evaluation of pancreatic cysts
Key inclusion criteria (2 listed)
- Adult patients age 18 years and older
- Referred for assessment of one or more pancreatic cyst.
Key exclusion criteria (7 listed)
- Medically ill patients with ASA class 4 or greater.
- History of chronic kidney disease with a serum creatinine > 2.0 mg/dl or estimated glomerulofiltration rate (eGFR) < 30 ml/min, dialysis patients, acute renal failure, cirrhosis of the liver, chronic hepatitis, prior nephrectomy or kidney or liver transplantation.
- History of moderate (generalized hives) or severe (facial swelling, airway reaction) reaction to intravenous radiographic contrast material.
- History of obstruction in the upper GI tract such as esophageal or pyloric stricture, which would not allow passage of an endoscope.
- Bleeding diathesis (clotting problems) or a history of thrombocytopenia (low platelet count <50,000).
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
Prevalence and incidence of malignant pancreatic cysts
Time frame: 3-6 years
1)to determine the prevalence and incidence of malignancy in pancreatic cysts according to cyst size and concerning features
6 secondary outcomes
Biomarkers to predict type of pancreatic cyst
Time frame: 3-6 years
Biomarker panel in pancreatic juice as indicator to type of pancreatic cyst
Time frame: 3-6 years
Compare CT with EUS and MRI for diagnosing pancreatic cysts.
Time frame: 3-6 year
Difference EUS/CT or MRCP in diagnosis of malignant pancreatic cysts
Time frame: 3-6 years
Associated factors for with multivariate model for malignant pancreatic cyst
Time frame: 3-6 years
Model for prediction of malignant pancreatic cysts
Time frame: 3-6 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 27 Feb 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 principal investigator
John Hopkins University, School of Medicine
2 sites 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 Pancreatic Cancer, run by Johns Hopkins University at 2 sites 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 2 inclusion and 7 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Prevalence and incidence of malignant pancreatic cysts (time frame: 3-6 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 27 Feb 2026.