TrialPath
← Back to searchRecruiting

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

NCT01000259 · GOG Foundation
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer
About this study
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.
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
Study design
Enrollment target: 174 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2004-09
Last updated: 2017-05-05
Interventions
Other: Laboratory Biomarker Analysis
Primary outcomes
  • Overall survival curves (Baseline)
  • Progression-free survival curves (Baseline)
Sponsor
Gynecologic Oncology Group · network
With: National Cancer Institute (NCI)
Contacts & investigators
InvestigatorGeorge Coukos · principal_investigator, Gynecologic Oncology Group
All locations (1)
Gynecologic Oncology GroupRecruiting
Philadelphia, Pennsylvania, United States
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer · TrialPath