Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
NCT ID: NCT01000259
Last Updated: 2017-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
174 participants
OBSERVATIONAL
2004-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Groups
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Ancillary-Correlative
Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining.
Laboratory Biomarker Analysis
Samples are analyzed in laboratory studies
Interventions
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Laboratory Biomarker Analysis
Samples are analyzed in laboratory studies
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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George Coukos
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2011-02279
Identifier Type: REGISTRY
Identifier Source: secondary_id
GOG-8005
Identifier Type: -
Identifier Source: secondary_id
CDR0000391277
Identifier Type: -
Identifier Source: secondary_id
GOG-8005
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-8005
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-8005
Identifier Type: -
Identifier Source: org_study_id
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