Pancreatic CystCLIMBNCT03492151
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
An observational study of Pancreatic Cyst, run by Ohio State University Comprehensive Cancer Center at 10 sites in United States.
Trial summary
The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst
- How many people
- 500 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Oct 2018to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 for this study will be identified from patients referred for diagnostic EUS-FNA of PCLs for a non-study indication by a physician responsible for their care (i.e., gastroenterologists, oncologists, general internists, and surgeons) either at the primary study center.
Who may be able to join
- Patient age 18 years or older
- All patients referred for EUS-FNA of accessible PCL where surgery is contemplated
- Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies
Who cannot join
- Unable to obtain informed consent
- Unable to tolerate the procedure
- Women with known pregnancy at time of procedure
- Patient age less than 18 years
- Bleeding diathesis
- Known allergy to fluorescein
- Prior pancreatic cancer
- Prior pancreatic surgery
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Diana Burke contact
10 sites in 1 country
United States10 sites, 9 recruiting
- Recruiting
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Kylie Ning, kning2@jhu.edu
Anne Marie Lennon
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roya Dastjerdi, MPH, rdastjer@bidmc.harvard.edu
Mandeep Sawhney, MD
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Megan Fry, 614-293-1056, Megan.Fry@osumc.edu
- Active, not recruiting
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805
- Recruiting
NYU Langone Health
Garden City, New York, 11530
Maria Marotta-Kollarus, Maria.Kollarus@nyulangone.org
Jessica Widmer, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Chandra Kovvali, 713-798-2308, ckovvali@bcm.edu
Mohamed Othman, MD
- Recruiting
Yale School of Medicine
New Haven, Connecticut, 06510
Chloe Bennett, chloe.bennett@yale.edu
Thiruvengadam Muniraj, MD, MRCP
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sharon Slomovich, Sharon.slomovich@snch.org
Frank Gress, MD
- Recruiting
Mayo Clinic Scottsdale Campus
Scottsdale, Arizona, 85259
Veronica Oria, Oria.Veronica@mayo.edu
Rahul Pannala
- Recruiting
Stanford Hospital
Stanford, California, 94305
Samer El-Dika, Samereld@stanford.edu
Samer El-Dika
About this study
Official title: Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.
- Conditions
- Pancreatic Cyst
- Keywords
- Confocal laser endomicroscopy, pancreatic cancer, IPMN
- Medical subject headings
- Pancreatic Cyst, Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of PCL diagnosis
Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia.
Measured: 48 months
Accuracy of risk-stratification of IPMNs
Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs
Measured: 48 months
Secondary outcomes (1)
Imaging quality
Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Gastroenterology, The National Pancreas Foundation
- Responsible party
- Principal investigator, Somashekar Krishna, Ohio State University
- Investigators
- Somashekar Krishna, MD, MPH, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492151
- Sponsor's protocol ID
- 2017C0192
- Acronym
- CLIMB
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2018
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Firkins SA, Chen W, Krishna SG. Morphologic and Microscopic Characterization of an Unusual Pancreatic Cystic Lesion. Gastroenterology. 2021 May;160(6):e14-e16. doi: 10.1053/j.gastro.2020.09.046. Epub 2020 Oct 8. No abstract available.
PubMed 33039474
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
- ClinicalTrials.gov ID
- NCT03492151
- Acronym / sponsor ID
- CLIMB / 2017C0192
- Conditions
- Pancreatic Cyst
- Keywords
- Confocal laser endomicroscopy, pancreatic cancer, IPMN
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American College of Gastroenterology, The National Pancreas Foundation
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Apr 2018 (actual)
- 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 study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.
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
- Subjects for this study will be identified from patients referred for diagnostic EUS-FNA of PCLs for a non-study indication by a physician responsible for their care (i.e., gastroenterologists, oncologists, general internists, and surgeons) either at the primary study center.
Key inclusion criteria (3 listed)
- Patient age 18 years or older
- All patients referred for EUS-FNA of accessible PCL where surgery is contemplated
- Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies
Key exclusion criteria (8 listed)
- Unable to obtain informed consent
- Unable to tolerate the procedure
- Women with known pregnancy at time of procedure
- Patient age less than 18 years
- Bleeding diathesis
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
Accuracy of PCL diagnosis
Time frame: 48 months
Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia.
Accuracy of risk-stratification of IPMNs
Time frame: 48 months
Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs
1 secondary outcome
Imaging quality
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 33039474Firkins SA, Chen W, Krishna SG. Morphologic and Microscopic Characterization of an Unusual Pancreatic Cystic Lesion. Gastroenterology. 2021 May;160(6):e14-e16. doi: 10.1053/j.gastro.2020.09.046. Epub 2020 Oct 8. No abstract available.
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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.
Diana Burke contact
Somashekar Krishna, MD, MPH principal investigator
Ohio State University
10 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 Cyst, run by Ohio State University Comprehensive Cancer Center at 10 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Fry (614-293-1056, Megan.Fry@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of PCL diagnosis (time frame: 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492151, which also lists 1 linked publication.
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 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.