OX-40 Protein Expression in the Sentinel Lymph Nodes of Patients With Cancer

Cancer Clinical Trial

Official title:

Study of The Examination of Sentinel Lymph Nodes for OX-40 Expression in Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900302
• Other study ID #: CDR0000443230
• Secondary ID: P30CA069533OHSU-
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: February 9, 2016
• Start date: April 2005
• Est. completion date: March 2011

Study information

• Verified date: February 2016
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

OBJECTIVES:

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed cancer, including, but not limited to, the following:

• Melanoma

• Breast cancer

• Invasive squamous cell cancer

• Other cancers for which patients underwent or will undergo the following:

• Adequate archived paraffin-embedded tissue for making slides for immunostaining

• Adequate freshly removed sentinel lymph node (and primary tumor, if available) tissue for laboratory assays

• Clinical data and date of last follow-up on tumor stage and status must be available

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cancer

Intervention

Genetic:
• protein expression analysis
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. Two independent viewers, who will be blinded to clinical data and outcome at the time of scoring, will review all slides. Scores from these independent readings will be compared, and differences were resolved upon mutual review of given cases. We will estimate the distribution of OX-40 IHC score by tumor type and tumor stage. OX-40 IHC score will be correlated with the IHC scores of other markers using Spearman's correlation coefficient. Kruskal-Wallis test will be used to test whether OX-40 IHC score is comparable between tumor type and tumor stage

Other:
• immunohistochemistry staining method
5-micron sections will be cut, mounted on capillary gap slides and dried in a 60°C oven. The slides will then be then deparaffinized in xylene baths and gradually hydrated in graded alcohol. For epitope retrieval, the slides are placed in baths of 0.5 M Tris buffer at pH 10 and subjected to microwave irradiation for at least 19 minutes. The slides will be cooled and washed with deionized water and 0.05% TWEEN. They are then placed in a blocking solution of 0.3% bovine serum albumin, drained, and placed in wells of their primary antibody in a humidity chamber at room temperature overnight. Primary mouse antihuman antibodies will include anti-OX-40, anti-CD4, and anti-HLA class II. Anti-rat CD45 will be used as a negative control for each section. The slides will then be then washed and placed in their appropriate biotinylated anti-mouse secondary antibody for 24 minutes. Endogenous peroxidase in the samples is blocked using a solution of 3% hydrogen peroxide.
• laboratory biomarker analysis
Lymphocytes will be collected from fresh tissue and peripheral blood (PBLs) for use in marker analysis and in vitro assays of immune function. Tissues will be dissociated to obtain lymphocytes

Procedure:
• biopsy
De-identified tissue samples will be obtained from the OHSU Pathology Department. Tissues will consist of paraffin blocks collected either prospectively for previous cases, or fresh tissue collected prospectively for patients enrolled in the study. For either case, tissue will be collected only after tissue necessary for the adequate rendering of the pathologic diagnosis has been collected by the pathology Department. Thus, the collection of tissue will not compromise patient diagnosis/care.

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OX-40 expression	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	During immunostaining	No
Primary	Disease-free survival	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	During data analysis	No