Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions

Study acronym: CLIMB
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2026 → Dec 31, 2028
See other at-risk trials from Ohio State University Comprehensive Cancer Center

Record History

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  1. Primary and study completion pushed from Dec 31, 2026 to Dec 31, 2028
    • Eligibility criteria expanded, about 11 words
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv13
  3. Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v12
  4. Lead sponsor: Ohio State University to Ohio State University Comprehensive Cancer Centerv11
  5. Primary endpoints: 1 to 2
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    • Site contacts updated at 1 of 10 sites
    v10
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  1. Study sites: 12 to 10v9
  2. Study sites: 10 to 12v8
  3. Re-verified, no change to tracked fieldsv7
  4. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2024v6
  5. Enrollment target: 300 to 500
    • Study sites: 6 to 10
    v5
  6. Site details revised at 1 of 6 sitesv4
  7. Study sites: 1 to 6v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2018 to Oct 1, 2018
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03492151
Lead Sponsor Ohio State University Comprehensive Cancer Center
Collaborators: American College of Gastroenterology, The National Pancreas Foundation
Conditions
(from sponsor)		 Pancreatic Cyst
Related terms Pancreatic Cyst, Pancreatic Neoplasms
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov