Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer

NCT00899704 | Withdrawn

• 2 other identifiers: ACOSOG-Z3081CDR0000589332
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at tissue samples in predicting oral cancer in patients who have undergone neck dissection for oral cancer.

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; tongue cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  Up to 5 years

Study Arms (1)

Group 1

Patient tissue samples are screened using polymerase chain reaction (PCR) for human papilloma virus-specific primers. Samples are analyzed to identify a nodal-metastasis signature for oral squamous cell carcinoma. Samples also undergo microarray analysis to quantify expression levels for targeted genes. Initial data analysis is performed using Affymetrix® Microarray Suite 5.0 to quantify expression levels for targeted genes.

Genetic: microarray analysis; Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction; Other: diagnostic laboratory biomarker analysis

Interventions

microarray analysis GENETIC

Also known as: gene expression profiling

Group 1

allele-specific oligonucleotide real-time quantitative polymerase chain reaction GENETIC

Also known as: ASO RQ-PCR

Group 1

diagnostic laboratory biomarker analysis OTHER

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient tissue samples are screened using polymerase chain reaction (PCR) for human papilloma virus-specific primers. Samples are analyzed to identify a nodal-metastasis signature for oral squamous cell carcinoma. Samples also undergo microarray analysis to quantify expression levels for targeted genes. Initial data analysis is performed using Affymetrix® Microarray Suite 5.0 to quantify expression levels for targeted genes. are

* Have a primary tumor specimen banked by the American College of Surgeons Oncology Group (ACOSOG) as part of clinical trial ACOSOG-Z0360 \* All tumor specimens are squamous cell carcinomas of the tongue, floor of the mouth, or gingiva * All patients have undergone neck dissections \* Pathologically confirmed nodal stage (negative or positive)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Tongue Neoplasms

Interventions

Microarray Analysis; Gene Expression Profiling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical Procedures; Investigative Techniques; Genetic Techniques

Study Officials

• Barry Ziober, PhD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: March 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

US (1)