Randomized Trial for Optimal Number of Passes Required for Molecular Profiling During EUS-FNB of Pancreatic Cancer
NCT ID: NCT05043532
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
33 participants
INTERVENTIONAL
2021-08-18
2023-06-30
Brief Summary
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Detailed Description
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Molecular profiling is becoming increasingly important in the management of pancreatic adenocarcinoma for targeted therapy. As the procurement of core tissue is possible with EUS-FNB, adequate tissue can now be obtained for molecular profiling. However, the number of passes required during EUS-FNB to obtain sufficient quantity of core tissue to successfully perform molecular profiling is unknown, although usually 2-3 passes are performed as standard of care practice.
The primary aim of this study is therefore to elucidate the optimal number of passes required during EUS-FNB to procure adequate tissue for molecular profiling in patients with pancreatic adenocarcinoma.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Two passes performed during EUS-FNB of pancreatic adenocarcinoma
Once the pancreatic mass is identified on endoscopic ultrasound examination, total of two passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.
2 passes during EUS-guided fine needle biopsy
Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of two passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.
Three passes performed during EUS-FNB of pancreatic adenocarcinoma
Once the pancreatic mass is identified on endoscopic ultrasound examination, total of three passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.
3 passes during EUS-guided fine needle biopsy
Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of three passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.
Interventions
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2 passes during EUS-guided fine needle biopsy
Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of two passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.
3 passes during EUS-guided fine needle biopsy
Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of three passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.
Eligibility Criteria
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Inclusion Criteria
2. Suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy
Exclusion Criteria
2. Females who are pregnant
3. Pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound
4. Biopsied pancreatic mass is not adenocarcinoma on pathology
18 Years
ALL
No
Sponsors
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Orlando Health, Inc.
OTHER
Responsible Party
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Principal Investigators
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Ji Young Bang, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Orlando Health
Locations
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Orlando Health
Orlando, Florida, United States
Countries
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Other Identifiers
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1741103
Identifier Type: OTHER
Identifier Source: secondary_id
21.069.05
Identifier Type: -
Identifier Source: org_study_id
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