Head and Neck NeoplasmsNCT00200486
Molecular and Genomic Profiling of Head and Neck Tumors
An observational study of Head and Neck Neoplasms, run by Montefiore Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Neoplasms
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2002to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with tumors of the head and neck who ar ehaving diagnostic biopsy or surgical resection of primary lesions or recurrences
Who may be able to join
- actual or suspected malignant or non-malignant tumors of the head and neck
- planned biopsy and/or resection, or availability of paraffin embedded or stored frozen tumor tissue for non-genetic analysis
Who cannot join
- insufficient tissue available for both standard diagnostic evaluation and study specimen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stelby Augustine
The Bronx, New York, 10467
Stelby Augustine, RN, 718-920-7054, staugust@montefiore.org
Richard V Smith, MD, 718-920-2991, rsmith@montefore.org
About this study
Official title: Molecular and Genomic Profiling of Head and Neck Tumors to Explore Biomarkers Associated With Prognosis and Response to Therapy
The purpose of this study is to study the genetic profile of head and neck tumors and their relationship to treatment response and outcome
Read the 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 and/or sputum for head and neck squamous cell carcinoma and study the mechanism of action of these proteins.
- Conditions
- Head and Neck Neoplasms
- Keywords
- genetic microarray, head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of treatment response and prognosis (time to recurrence and survival) with genetic expression profile
Measured: 5 years
Secondary outcomes (1)
identify a series of diagnostic markers for head and neck tumors and study the mechanism of action of these proteins
Measured: variable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study start1 Oct 2002
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard V Smith, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200486
- Sponsor's protocol ID
- 02-05-127E
- Other IDs
- NIH-R21-CA104402, 6R21DE023941-03, 3P50DE019032-14S2, 3U54CA274321-02S1
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2005
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Stone A, Liu J, Lin J, Schiff BA, Ow TJ, Mehta V, Smith RV. Value of Adherence to Posttreatment Follow-Up Guidelines for Head and Neck Squamous Cell Carcinoma. Laryngoscope. 2024 Feb;134(2):708-716. doi: 10.1002/lary.30909. Epub 2023 Jul 26.
PubMed 37493178Shrivastava N, Chavez CG, Li D, Mehta V, Thomas C, Fulcher CD, Kawachi N, Bottalico DM, Prystowsky MB, Basu I, Guha C, Ow TJ. CDK4/6 Inhibition Induces Senescence and Enhances Radiation Response by Disabling DNA Damage Repair in Oral Cavity Squamous Cell Carcinoma. Cancers (Basel). 2023 Mar 28;15(7):2005. doi: 10.3390/cancers15072005.
PubMed 37046664Li D, Thomas C, Shrivastava N, Gersten A, Gadsden N, Schlecht N, Kawachi N, Schiff BA, Smith RV, Rosenblatt G, Augustine S, Gavathiotis E, Burk R, Prystowsky MB, Guha C, Mehta V, Ow TJ. Establishment of a diverse head and neck squamous cancer cell bank using conditional reprogramming culture methods. J Med Virol. 2023 Feb;95(2):e28388. doi: 10.1002/jmv.28388.
PubMed 36477880
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Genomic Profiling of Head and Neck Tumors to Explore Biomarkers Associated With Prognosis and Response to Therapy
- ClinicalTrials.gov ID
- NCT00200486
- Acronym / sponsor ID
- 02-05-127E
- Conditions
- Head and Neck Neoplasms
- Keywords
- genetic microarray, head and neck cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI)
- Study start
- 1 Oct 2002
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and/or sputum for head and neck squamous cell carcinoma and study the mechanism of action of these proteins.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with tumors of the head and neck who ar ehaving diagnostic biopsy or surgical resection of primary lesions or recurrences
Key inclusion criteria (2 listed)
- actual or suspected malignant or non-malignant tumors of the head and neck
- planned biopsy and/or resection, or availability of paraffin embedded or stored frozen tumor tissue for non-genetic analysis
Key exclusion criteria (1 listed)
- insufficient tissue available for both standard diagnostic evaluation and study specimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation of treatment response and prognosis (time to recurrence and survival) with genetic expression profile
Time frame: 5 years
1 secondary outcome
identify a series of diagnostic markers for head and neck tumors and study the mechanism of action of these proteins
Time frame: variable
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Results publication: PubMed 37493178Stone A, Liu J, Lin J, Schiff BA, Ow TJ, Mehta V, Smith RV. Value of Adherence to Posttreatment Follow-Up Guidelines for Head and Neck Squamous Cell Carcinoma. Laryngoscope. 2024 Feb;134(2):708-716. doi: 10.1002/lary.30909. Epub 2023 Jul 26.
- Results publication: PubMed 37046664Shrivastava N, Chavez CG, Li D, Mehta V, Thomas C, Fulcher CD, Kawachi N, Bottalico DM, Prystowsky MB, Basu I, Guha C, Ow TJ. CDK4/6 Inhibition Induces Senescence and Enhances Radiation Response by Disabling DNA Damage Repair in Oral Cavity Squamous Cell Carcinoma. Cancers (Basel). 2023 Mar 28;15(7):2005. doi: 10.3390/cancers15072005.
- Results publication: PubMed 36477880Li D, Thomas C, Shrivastava N, Gersten A, Gadsden N, Schlecht N, Kawachi N, Schiff BA, Smith RV, Rosenblatt G, Augustine S, Gavathiotis E, Burk R, Prystowsky MB, Guha C, Mehta V, Ow TJ. Establishment of a diverse head and neck squamous cancer cell bank using conditional reprogramming culture methods. J Med Virol. 2023 Feb;95(2):e28388. doi: 10.1002/jmv.28388.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard V Smith, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stelby Augustine, RN (718-920-7054, staugust@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of treatment response and prognosis (time to recurrence and survival) with genetic expression profile (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00200486, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.