Ignite Creation Date:
2024-05-06 @ 12:41 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01630122
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2012-06-15
Brief Title:
Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 AS 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 11 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 objectivewill be assayed on the QGS platform
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 11 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 objectivewill be assayed on the QGS platform
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCCWFU 97112 | OTHER | Wake Forest University Health Sciences | None |