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 May 2015 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01000259
First received: October 22, 2009
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Stage IIIA Ovarian Cancer
Stage IIIB Ovarian Cancer
Stage IIIC Ovarian Cancer
Stage IV Ovarian Cancer
Other: Laboratory Biomarker Analysis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 174
Study Start Date: September 2004
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative
Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining.
Other: Laboratory Biomarker Analysis
Samples are analyzed in laboratory studies

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient who have undergone surgery for ovarian cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000259

Locations
United States, Pennsylvania
Gynecologic Oncology Group Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: George Coukos    215-662-3316    gcoukos@mail.obgyn.upenn.edu   
Principal Investigator: George Coukos         
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: George Coukos Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01000259     History of Changes
Other Study ID Numbers: GOG-8005, NCI-2011-02279, GOG-8005, CDR0000391277, GOG-8005, GOG-8005, U10CA027469
Study First Received: October 22, 2009
Last Updated: May 27, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on June 30, 2015