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NCT01455311 · ClinicalTrials.gov registry record
Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in Diagnosis of Cystic Pancreatic Tumors
A clinical trial, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- 21
- Enrollment target
NCT01455311: Clinical Trial study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01455311 is a clinical trial that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01455311 was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- 21 participants
- Enrollment target
Study Summary
The goal of this study is to compare a sample of the cyst taken by a standard method (fine needle aspiration) to the sample taken by a new method using a device called the EchoBrush to see which method is more accurate at diagnosing cancer. We will also look at proteins (also called biomarkers) in the samples to see if they predict whether or not the cyst is cancerous.
Primary Outcome
The difference in diagnostic accuracy between the cytological grade of dysplasia on aspirated cyst fluid cytology (Specimen/ Group 1) and Echo Brush cytology (Specimen/ Group 2) when compared to surgical histology (Specimen 3). Specifically, the cellularity (scored 0 to 3) of specimen 1 will be compared to specimen 2 using the two-sample proportion test. In addition, the Spearman's rank correlation will be used to calculate the correlation between cytological grade of dysplasia of specimen 1 to
Interventions
- PROCEDURE EUS Guided Fine Needle Aspiration
- PROCEDURE EUS Guided EchoBrush Sampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-01 |
Why NCT01455311 stopped before completion
NCT01455311 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 21 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which EUS Guided Fine Needle Aspiration is the first listed.
NCT01455311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01455311 about?
NCT01455311 is a clinical study titled "Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in Diagnosis of Cystic Pancreatic Tumors". The goal of this study is to compare a sample of the cyst taken by a standard method (fine needle aspiration) to the sample taken by a new method using a device called the EchoBrush to see which method is more accurate at diagnosing cancer. We will also look at proteins (also called biomarkers) in t...
What is the current status of trial NCT01455311?
This trial is currently terminated. The enrollment target is 21 participants. The study started on 2010-09. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01455311?
The interventions under investigation include: EUS Guided Fine Needle Aspiration (PROCEDURE), EUS Guided EchoBrush Sampling (PROCEDURE).
Who is sponsoring clinical trial NCT01455311?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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