Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laboratory Biomarker Analysis.
- Who it may be relevant to
- Registry conditions: Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer, Stage IV Ovarian Cancer. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer
Overview
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.
Detailed description
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.
Interventions
- Other Laboratory Biomarker Analysis
Samples are analyzed in laboratory studies
Primary outcome measures
- Overall survival curves [Time frame: Baseline]
- Progression-free survival curves [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study locations
United States · 1 center
- Gynecologic Oncology Group — Philadelphia
Identifiers
NCT: NCT01000259 · GOG-8005 · NCI-2011-02279 · GOG-8005 · CDR0000391277 · GOG-8005 · GOG-8005 · U10CA027469