NCT00899340

Brief Summary

RATIONALE: Studying the proteins expressed in samples of tumor tissue from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors plan better treatment for patients with cancer of the oropharynx. PURPOSE: This laboratory study is looking at protein expression in tumor tissue samples from patients with cancer of the oropharynx.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

April 2, 2013

Status Verified

March 1, 2013

Enrollment Period

1.8 years

First QC Date

May 9, 2009

Last Update Submit

March 29, 2013

Conditions

Keywords

recurrent squamous cell carcinoma of the oropharynxstage I squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (2)

  • Development of biomarkers for early detection or recurrence surveillance

    after 7 months of tissue collection

  • Identification of therapeutic targets and individualization of treatment based on the biology of squamous cell carcinoma of the oropharynx

    after 7months of tissue collection

Interventions

profiles of HPV(+) and (-) HNSCCs

microarray analysis

Also known as: SAM - significance Analysis of microarrays

protein expression analysis

immunohistochemistry staining method

laboratory biomarker analysis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

community sample

You may qualify if:

  • Diagnosis of squamous cell carcinoma of the oropharynx
  • Tumor tissue samples available from Vanderbilt Head and Neck Tumor Repository and Vanderbilt Pathology archives

You may not qualify if:

  • Not specified
  • PRIOR CONCURRENT THERAPY:
  • Not specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Gene Expression ProfilingMicroarray AnalysisImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesMicrochip Analytical ProceduresHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Barbara Murphy, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Medical Oncologist

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 2, 2013

Record last verified: 2013-03