Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200486
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2005-09-12
Brief Title:
Molecular and Genomic Profiling of Head and Neck Tumors
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Molecular and Genomic Profiling of Head and Neck Tumors to Explore Biomarkers Associated With Prognosis and Response to Therapy
Status:
RECRUITING
Status Verified Date:
2024-02
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 purpose of this study is to study the genetic profile of head and neck tumors and their relationship to treatment response and outcome
Detailed Description:
Previous research by our group using genetic microarray analysis of HNSCC and normal keratinocytes has identified two distinct groups of genetic expression based on clustering patterns of a subgroup of genes Clinical data was summarized for each group and overall patient segregation by gene expression profiling was a better predictor of outcome than clinicopathological variables Further analysis identified 375 genes that discriminate between the genotypic subtypes of HNSCC Overall our preliminary data has shown that the pattern of global gene expression in a HNSCC specimen can be used as a predictor of prognosis We isolated subsets of genes showing the greatest patterns of divergence in gene expression We have also identified 366 over-expressed and 246 underexpressed genes when comparing primary tumor to normal surgical margins and have identified a similar number of genes whose expression has changed when comparing primary tumor to lymph node metastasis Combining these data sets we have identified genes which consistently increase or decrease expression during progression from normal tissue to primary tumor and subsequently to metastatic node We have selected several candidate genes for subsequent analysis using HNSCC tissue arrays Through DNA microarray analysis and other techniques for looking at genetic and molecular characteristics a more detailed knowledge of the malignant transformation process and alterations with therapy in these patients may be obtained This study will seek to perform comprehensive molecular and genetic profiling to improve biomarker development in HNSCC and correlate this data with patient clinical data Ultimately it is hoped that tumor specific genetic abnormalities may be identified which could provide targets for treatment strategies such as gene therapy immunotherapy or other interventions
Study Objectives
To evaluate gene expression patterns in human head and neck squamous cell carcinoma and correlate this with treatment response both surgical and non-surgical
To identify a series of diagnostic markers in blood urine andor sputum for head and neck squamous cell carcinoma and study the mechanism of action of these proteins
Study Objectives
To evaluate gene expression patterns in human head and neck squamous cell carcinoma and correlate this with treatment response both surgical and non-surgical
To identify a series of diagnostic markers in blood urine andor sputum for head and neck squamous cell carcinoma and study the mechanism of action of these proteins
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| NIH-R21-CA104402 | None | None | None |
| 6R21DE023941-03 | NIH | None | None |
| 3P50DE019032-14S2 | NIH | None | httpsreporternihgovquickSearch3P50DE019032-14S2 |