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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Up to 120 years
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: De-identified tissue samples will be obtained from the OHSU Pathology Department

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Cancer

Being tested

protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis, biopsy

Keywords

male breast cancer, recurrent breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, squamous cell carcinoma of the anus, squamous cell carcinoma of the bladder, squamous cell carcinoma of the esophagus, squamous cell carcinoma of the gallbladder, squamous cell carcinoma of the skin, squamous cell carcinoma of the vulva, squamous cell lung cancer, vaginal squamous cell carcinoma, stage I squamous cell carcinoma of the hypopharynx

Medical subject headings

Neoplasms, Breast Neoplasms, Male, Breast Neoplasms, Anus Neoplasms, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Salivary Gland Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• protein expression analysisGenetic

  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

• immunohistochemistry staining methodOther

  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 analysisOther

  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

• biopsyProcedure or surgery

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

   Measured: During immunostaining

2. 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

   Measured: During data analysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted12 May 2009 (estimated)
2. Study startApr 2005
3. Primary completionMar 2011
4. Study completionMar 2011

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for CancerStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.