- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2021-08-18
2023-03-01
2023-06-30
33
NCT05043532
Orlando Health, Inc.
Orlando Health, Inc.
INTERVENTIONAL
Randomized Trial for Optimal Number of Passes Required for Molecular Profiling During EUS-FNB of Pancreatic Cancer
This is a randomized trial to evaluate the optimal number of passes required during endoscopic ultrasound-guided fine needle biopsy for molecular profiling in pancreatic cancer
Endoscopic ultrasound-guided fine needle tissue acquisition is currently the gold standard for sampling solid pancreatic masses. By using novel fine needle biopsy (FNB) needles during EUS-guided tissue sampling, core tissue samples can also now be obtained, with diagnostic adequacy of >90%. 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-09-07 | N/A | 2023-01-11 |
2021-09-07 | N/A | 2023-01-12 |
2021-09-14 | N/A | 2023-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: 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. | PROCEDURE: 2 passes during EUS-guided fine needle biopsy
|
| ACTIVE_COMPARATOR: 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. | PROCEDURE: 3 passes during EUS-guided fine needle biopsy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy | Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy of pancreatic adenocarcinoma, with comparison between two and three passes during fine needle biopsy | 7 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of actionable mutations detected on molecular profiling | Number of actionable mutations detected on molecular profiling | 7 days |
| Rate of technical success | Rate of technical success of EUS-guided fine needle biopsy. Technical success is defined as the successful completion of the EUS-guided fine needle biopsy procedure. | 1 day |
| Rate of procedure-related adverse events | Rate of procedure-related adverse events, defined as any adverse event occurring as a result of EUS-guided fine needle biopsy | 7 days |
| Type of actionable mutations detected on molecular profiling | Type of actionable mutations detected on molecular profiling | 7 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
