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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Gynecologic Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01000259
First received: October 22, 2009
Last updated: February 9, 2016
Last verified: February 2016

October 22, 2009
February 9, 2016
September 2004
January 2100   (final data collection date for primary outcome measure)
  • Overall survival curves [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate the survival curves, and the log-rank test will be used to test the difference between survival curves for TIL positive and negative patients. All of the tests will be two-sided and the significant levels will be set a 0.05.
  • Progression-free survival curves [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate the survival curves, and the log-rank test will be used to test the difference between survival curves for TIL positive and negative patients. All of the tests will be two-sided and the significant levels will be set a 0.05.
Ability of intratumoral tumor-infiltrating T lymphocytes (TILs) to predict progression-free survival of patients with suboptimally debulked disease or optimally debulked disease [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01000259 on ClinicalTrials.gov Archive Site
Not Provided
Ability of intratumoral TILs to predict overall survival of these 2 groups of patients [ Designated as safety issue: No ]
Not Provided
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Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
patients who have undergone surgery for ovarian cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IV Ovarian Cancer
Other: Laboratory Biomarker Analysis
Samples are analyzed in laboratory studies
Ancillary-Correlative
Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining.
Intervention: Other: Laboratory Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
174
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Female
Child, Adult, Senior
No
United States
 
NCT01000259
GOG-8005, NCI-2011-02279, GOG-8005, CDR0000391277, GOG-8005, GOG-8005, U10CA027469
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Not Provided
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: George Coukos Gynecologic Oncology Group
Gynecologic Oncology Group
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP