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NCT01630122 · ClinicalTrials.gov registry record
Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates
A clinical trial of Non-Small Cell Lung Cancer, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 103
- Enrollment target
- 1
- Study location
NCT01630122: Completed study of Non-Small Cell Lung Cancer, sponsored by Wake Forest University Health Sciences.
NCT01630122 is a study of Non-Small Cell Lung Cancer that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 103 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01630122, a study of Non-Small Cell Lung Cancer, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 103 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to demonstrate the feasibility of using a novel, validated panel of Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the "A/S signature) as a diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies. Objectives: 1. To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC. 2. To define a "fixed statistical model" of histologic subtype prediction in NSCLC. Study methods: To establish FNA biopsy requirements for gene expression-based subtype classification of NSCLC, patients with presumed newly diagnosed NSCLC, where radiographic studies and clinical description favor a probable diagnosis of NSCLC, will undergo FNA biopsy according to current standard techniques . For this part of the study, approximately 40 biopsies of confirmed NSCLC will be collected for analysis. To define a fixed statistical model of histologic subtype prediction in NSCLC, we will prospectively collect 50 FNAs. These FNAs will represent Adenocarcinoma (AC) and Squamous Cell Carcinoma (SCC) cases at a ratio of approximately 1:1. Additional cases of not otherwise specified (NOS), should they be encountered, may also be collected for later analysis. FNA samples qualified based on cell number or ribonucleic acid (RNA) yield (depending on the findings of our primary objective)will be assayed on the QGS platform.
Primary Outcome
To test a an 8-gene panel's accuracy in discriminating Non-Small Cell Lung Cancer tumors subtypes that are relevant to treatment and expected outcomes.
Conditions Studied
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-08-18 |
What the finished NCT01630122 record still lists
NCT01630122 is an observational study that tracks outcomes without assigning an intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT01630122 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01630122 about?
NCT01630122 is a clinical study titled "Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates". The goal of this study is to demonstrate the feasibility of using a novel, validated panel of Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the "A/S signature) as a diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies. Objectives: 1. To establish FNA biops...
What is the current status of trial NCT01630122?
This trial is currently completed. The enrollment target is 103 participants. The study started on 2012-06. Estimated completion is 2015-08-18.
What conditions does trial NCT01630122 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
Who is sponsoring clinical trial NCT01630122?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01630122 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01630122's enrollment target sits among peer trials
103 229th of 454 higher than 225 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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