- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01000259
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
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Recruiting
- Gynecologic Oncology Group
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Contact:
- George Coukos
- Phone Number: 215-662-3316
- Email: gcoukos@mail.obgyn.upenn.edu
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Principal Investigator:
- George Coukos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Description
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 Plan
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ancillary-Correlative
Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining.
|
Samples are analyzed in laboratory studies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival curves
Time Frame: Baseline
|
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.
|
Baseline
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Progression-free survival curves
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: George Coukos, Gynecologic Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- GOG-8005 (Other Identifier: CTEP)
- U10CA027469 (U.S. NIH Grant/Contract)
- NCI-2011-02279 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000391277
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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