Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions (CLIMB)
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| ClinicalTrials.gov Identifier: NCT03492151 |
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Recruitment Status :
Recruiting
First Posted : April 10, 2018
Last Update Posted : October 14, 2022
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Sponsor:
Ohio State University
Collaborators:
American College of Gastroenterology
The National Pancreas Foundation
Information provided by (Responsible Party):
Somashekar Krishna, Ohio State University
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Brief 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. 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.
| Condition or disease |
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| Pancreatic Cyst |
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions |
| Actual Study Start Date : | October 1, 2018 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Diagnostic Imaging
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Imaging quality [ Time Frame: 48 months ]Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions
Biospecimen Retention: Samples Without DNA
Pancreas cyst fluid from EUS-nCLE
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492151
Contacts
| Contact: Megan Fry | 614-293-1056 | Megan.Fry@osumc.edu |
Locations
| United States, Arizona | |
| Mayo Clinic Scottsdale Campus | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Contact: Veronica Oria Oria.Veronica@mayo.edu | |
| Principal Investigator: Rahul Pannala | |
| United States, California | |
| Stanford Hospital | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Samer El-Dika Samereld@stanford.edu | |
| Principal Investigator: Samer El-Dika | |
| United States, Connecticut | |
| Yale School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Christina Rose christina.rose@yale.edu | |
| Principal Investigator: Thiruvengadam Muniraj, MD, MRCP | |
| United States, Indiana | |
| Parkview Hospital Randallia | Recruiting |
| Fort Wayne, Indiana, United States, 46805 | |
| Contact: Heather Sparks Heather.Sparks@parkview.com | |
| Principal Investigator: Neil Sharma | |
| United States, Maryland | |
| The Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Vaishnavi Sawant vsawant1@jhmi.edu | |
| Principal Investigator: Anne Marie Lennon | |
| United States, Minnesota | |
| University of Minnesota | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Ghislaine Feussom feuss001@umn.edu | |
| United States, New York | |
| Icahn School of Medicine at Mount Sinai | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Rebekah Dixon rebekah.dixon@mountsinai.org | |
| Principal Investigator: Christopher DiMaio, MD | |
| United States, Ohio | |
| The Ohio State University Wexner Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Megan Fry 614-293-1056 Megan.Fry@osumc.edu | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Chandra Kovvali 713-798-2308 ckovvali@bcm.edu | |
| Principal Investigator: Mohamed Othman, MD | |
| The University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Manoop Bhutani, MD | |
| Principal Investigator: Manoop Bhutani, MD | |
Sponsors and Collaborators
Ohio State University
American College of Gastroenterology
The National Pancreas Foundation
Investigators
| Principal Investigator: | Somashekar Krishna, MD, MPH | The Ohio State University Wexner Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Somashekar Krishna, Assistant Professor, Ohio State University |
| ClinicalTrials.gov Identifier: | NCT03492151 |
| Other Study ID Numbers: |
2017C0192 |
| First Posted: | April 10, 2018 Key Record Dates |
| Last Update Posted: | October 14, 2022 |
| Last Verified: | September 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Somashekar Krishna, Ohio State University:
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Confocal laser endomicroscopy |
Additional relevant MeSH terms:
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Pancreatic Cyst Cysts Neoplasms Pancreatic Diseases Digestive System Diseases |