Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer



Status:Recruiting
Conditions:Ovarian Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:September 2004

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Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer

This research study is looking at tumor tissue samples from patients who have undergone
surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of
tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor
infiltrating T cells can predict how patients will respond to treatment.

PRIMARY OBJECTIVES:

I. To validate the ability of intratumoral tumor-infiltrating T lymphocytes (TILs) to
predict progression-free survival (PFS) in patients with suboptimally debulked advanced
stage III or IV ovarian epithelial cancer.

II. To validate the ability of intratumoral TILs to predict PFS in patients with optimally
debulked disease.

SECONDARY OBJECTIVES:

I. To validate the ability of intratumoral TILs to predict overall survival of patients with
suboptimally debulked disease.

II. To validate the ability of intratumoral TILs to predict overall survival of patients
with optimally debulked disease.

OUTLINE:

Patients are stratified according to status of debulked disease (suboptimal vs optimal).

Previously collected tumor tissue samples are analyzed for tumor-infiltrating lymphocytes
(TIL) via immunohistochemistry and double immunofluorescence assays using standard
immunostaining.

Inclusion Criteria:

- Diagnosis of stage III or IV ovarian epithelial cancer and enrolled on Gynecologic
Oncology Group (GOG)-0136 and a GOG front-line platinum/taxol chemotherapy trial
(GOG-0114, GOG-132, GOG-0158, or GOG-0162)

- Must have fixed and paraffin-embedded tissue from primary surgery available from 1 of
the following sources:

- Patients enrolled on GOG-0136 and a GOG front-line platinum/taxol chemotherapy
trial(GOG-0114, GOG-0132, GOG-0158, and GOG-0162)

- Patients who have had either optimal or suboptimal cytoreductive surgery

- Patients for whom adequate demographic data, including major prognostic factors
and follow-up information, were collected

- Evaluable patients must have had measurable or nonmeasurable disease

- Demographic and follow-up data available
We found this trial at
1
site
Philadelphia, Pennsylvania 19103
Principal Investigator: George Coukos
Phone: 215-662-3316
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mi
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Philadelphia, PA
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