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NCT01769248 · ClinicalTrials.gov registry record · NA
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
A NA study of Pancreatic Cancer and Gastrointestinal Stromal Tumor, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 3
- Study locations
NCT01769248 is a NA study of Pancreatic Cancer and Gastrointestinal Stromal Tumor that has completed, run by Northwestern University. The registered enrollment target is 140 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (64% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT01769248, a NA study of Pancreatic Cancer and Gastrointestinal Stromal Tumor, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 3
- Study locations
Study Summary
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved. The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.
Conditions Studied
Interventions
- DEVICE Fine needle aspiration
- DEVICE Fine needle biopsy
Study Locations (3)
California
- UCLA Medical Center - Los Angeles
- California Pacific Medical Center - San Francisco
Florida
- Moffit Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01769248
The ClinicalTrials.gov registry entry for NCT01769248 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (64% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which Fine needle aspiration is the first listed.
NCT01769248 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, Florida.
Frequently Asked Questions
What is clinical trial NCT01769248 about?
NCT01769248 is a clinical study titled "Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle". Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with...
What is the current status of trial NCT01769248?
This trial is currently completed. It is a NA study. The enrollment target is 140 participants. The study started on 2012-09. Estimated completion is 2014-02.
What conditions does trial NCT01769248 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Gastrointestinal Stromal Tumor, Lymphadenopathy.
What interventions are being tested in trial NCT01769248?
The interventions under investigation include: Fine needle aspiration (DEVICE), Fine needle biopsy (DEVICE).
Who is sponsoring clinical trial NCT01769248?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01769248 being conducted?
This trial has 3 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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