Validation Of Tumor-Infiltrating T-Cells As A Biomarker For Advanced Epithelial Ovarian Cancer
N/A
N/A
Female
Ovarian Cancer
Trial Information
Validation Of Tumor-Infiltrating T-Cells As A Biomarker For Advanced Epithelial Ovarian Cancer
OBJECTIVES:
Primary
- 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.
- To validate the ability of intratumoral TILs to predict PFS in patients with optimally
debulked disease.
Secondary
- To validate the ability of intratumoral TILs to predict overall survival of patients
with suboptimally debulked disease.
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of stage III or IV ovarian epithelial cancer and enrolled on 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
t he 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
PATIENT CHARACTERISTICS:
- Demographic and follow-up data available
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Ability of intratumoral tumor-infiltrating T lymphocytes (TILs) to predict progression-free survival of patients with suboptimally debulked disease or optimally debulked disease
Safety Issue:
No
Principal Investigator
George Coukos, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Federal Government
Study ID:
CDR0000391277
NCT ID:
NCT01000259
Start Date:
Completion Date:
Related Keywords:
- Ovarian Cancer
- stage IV ovarian epithelial cancer
- stage IIIA ovarian epithelial cancer
- stage IIIB ovarian epithelial cancer
- stage IIIC ovarian epithelial cancer
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
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