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


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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

OX-40 expression

Outcome Description:

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

Outcome Time Frame:

During immunostaining

Safety Issue:

No

Principal Investigator

John T. Vetto, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000443230

NCT ID:

NCT00900302

Start Date:

April 2005

Completion Date:

March 2011

Related Keywords:

  • Cancer
  • 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
  • stage II squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage I verrucous carcinoma of the larynx
  • stage II squamous cell carcinoma of the larynx
  • stage II verrucous carcinoma of the larynx
  • stage III squamous cell carcinoma of the larynx
  • stage III verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage I verrucous carcinoma of the oral cavity
  • stage II verrucous carcinoma of the oral cavity
  • stage III verrucous carcinoma of the oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • recurrent verrucous carcinoma of the oral cavity
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • recurrent metastatic squamous neck cancer with occult primary
  • untreated metastatic squamous neck cancer with occult primary
  • stage I squamous cell carcinoma of the nasopharynx
  • stage II squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage I squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • salivary gland squamous cell carcinoma
  • stage I salivary gland cancer
  • stage II salivary gland cancer
  • stage III salivary gland cancer
  • stage IV salivary gland cancer
  • recurrent salivary gland cancer
  • squamous cell carcinoma of unknown primary
  • cervical squamous cell carcinoma
  • penile squamous cell carcinoma
  • recurrent anal cancer
  • stage I anal cancer
  • stage II anal cancer
  • stage IIIA anal cancer
  • stage IIIB anal cancer
  • stage IV anal cancer
  • recurrent bladder cancer
  • stage I bladder cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • stage IV bladder cancer
  • recurrent esophageal cancer
  • stage I esophageal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • localized gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable gallbladder cancer
  • recurrent vulvar cancer
  • stage I vulvar cancer
  • stage II vulvar cancer
  • stage III vulvar cancer
  • stage IV vulvar cancer
  • recurrent cervical cancer
  • stage IA cervical cancer
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • stage IIB cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • stage IVB cervical cancer
  • recurrent non-small cell lung cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent skin cancer
  • newly diagnosed carcinoma of unknown primary
  • recurrent carcinoma of unknown primary
  • recurrent penile cancer
  • stage I penile cancer
  • stage II penile cancer
  • stage III penile cancer
  • stage IV penile cancer
  • recurrent melanoma
  • stage IA melanoma
  • stage IB melanoma
  • stage IIA melanoma
  • stage IIB melanoma
  • stage IIC melanoma
  • stage IIIA melanoma
  • stage IIIB melanoma
  • stage IIIC melanoma
  • stage IV melanoma

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239