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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00899704
Other study ID # ACOSOG-Z3081
Secondary ID ACOSOG-Z3081CDR0
Status Withdrawn
Phase
First received
Last updated
Start date March 2008
Est. completion date March 2008

Study information

Verified date January 2019
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

OBJECTIVES:

- To test preliminary data from node-positive oral squamous cell carcinoma (OSCC) signatures for their ability to predict lymph-positive primaries using a cohort of OSCC tumors.

- To perform lymph node prediction using sentinel lymph node-biopsied primaries.

- To validate the preliminary data node-positive OSCC signature and test its ability to predict nodal status.

OUTLINE: 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
microarray analysis

allele-specific oligonucleotide real-time quantitative polymerase chain reaction

Other:
diagnostic laboratory biomarker analysis


Locations

Country Name City State
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival Up to 5 years
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