OX-40 Protein Expression in the Sentinel Lymph Nodes of Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT00900302|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : February 10, 2016
RATIONALE: Studying protein expression in sentinel lymph node tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is evaluating OX-40 protein expression in the sentinel lymph nodes of patients with cancer.
|Condition or disease||Intervention/treatment|
|Cancer||Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy|
- Determine the qualitative and quantitative expression of OX-40 and related markers in sentinel lymph nodes previously removed from patients with cancer.
- Determine the qualitative and quantitative expression of OX-40 and related markers in sentinel lymph nodes freshly removed from patients with cancer.
- Correlate the expression of OX-40 and related markers in sentinel lymph node tissue with expression in nonsentinel tissue from primary tumors and nonsentinel lymph nodes, tumor stage, and patient outcomes.
OUTLINE: Sections of primary tumors, nonsentinel lymph nodes, and sentinel lymph nodes will be analyzed for expression of OX-40 by immunohistochemistry. Sections of negative (no tumor metastases) lymph nodes will be used as internal controls. Fresh tissue and blood will be tested for marker analysis and in vitro assays of immune function.
PROJECTED ACCRUAL: A total of 100 specimens from sentinel lymph nodes previously removed from cancer patients and 100 specimens from sentinel lymph nodes freshly removed from cancer patients will be accrued for this study.
|Study Type :||Observational|
|Actual Enrollment :||98 participants|
|Official Title:||Study of The Examination of Sentinel Lymph Nodes for OX-40 Expression in Patients With Cancer|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Genetic: protein expression analysis
- OX-40 expression [ Time Frame: During immunostaining ]The first ten cases will be reviewed to assess the spectrum of OX-40 expression and to devise a semiquantitative scoring system. Each slide will be scanned in its entirety and then scored according to representative views with the greatest expression of immunostaining
- Disease-free survival [ Time Frame: During data analysis ]Kaplan-Maier method will be used to estimate the disease-free survival, and a log-rank test will be used to compare the disease-free survival between high vs. low OX-40 groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900302
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Principal Investigator:||John T. Vetto, MD, FACS||OHSU Knight Cancer Institute|