Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
Primary Purpose
Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer
Status
Recruiting
Phase
Locations
United States
Study Type
Observational
Intervention
Laboratory Biomarker Analysis
Sponsored by
About this trial
This is an observational trial for Stage IIIA Ovarian Cancer
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
Sites / Locations
- Gynecologic Oncology GroupRecruiting
Arms of the Study
Arm 1
Arm Type
Arm Label
Ancillary-Correlative
Arm Description
Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining.
Outcomes
Primary Outcome Measures
Overall survival curves
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01000259
First Posted
October 22, 2009
Last Updated
May 2, 2017
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01000259
Brief Title
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
Official Title
Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer
Study Type
Observational
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Recruiting
Study Start Date
September 2004 (undefined)
Primary Completion Date
January 2100 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer, Stage IV Ovarian Cancer
7. Study Design
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ancillary-Correlative
Arm Description
Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Samples are analyzed in laboratory studies
Primary Outcome Measure Information:
Title
Overall survival curves
Description
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.
Time Frame
Baseline
Title
Progression-free survival curves
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Coukos
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Coukos
Phone
215-662-3316
Email
gcoukos@mail.obgyn.upenn.edu
First Name & Middle Initial & Last Name & Degree
George Coukos
12. IPD Sharing Statement
Learn more about this trial
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
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