Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01630122
The ClinicalTrials.gov registry entry for NCT01630122 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT01630122 reports 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
RECRUITING · Phase 3
-
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
RECRUITING · Phase 1
-
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
RECRUITING · Phase 1
-
A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
RECRUITING · Phase 1
-
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.