Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
Purpose
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.
Conditions
- Stage IIIA Ovarian Cancer
- Stage IIIB Ovarian Cancer
- Stage IIIC Ovarian Cancer
- Stage IV Ovarian Cancer
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Ancillary-Correlative | Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining. |
|
Recruiting Locations
Philadelphia, Pennsylvania 19103
More Details
- NCT ID
- NCT01000259
- Status
- Recruiting
- Sponsor
- Gynecologic Oncology Group
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.