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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: Completed NA study of Pancreatic Cancer and Gastrointestinal Stromal Tumor, sponsored by Northwestern University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.
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 |
What the finished NCT01769248 record still lists
NCT01769248 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (64% lower).
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 a single indexed study location in 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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Where NCT01769248's enrollment target sits among peer trials
140 82nd of 278 higher than 196 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
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