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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01000259
First received: October 22, 2009
Last updated: July 8, 2011
Last verified: June 2005
  Purpose

RATIONALE: 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.

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.


Condition Intervention
Ovarian Cancer
Other: fluorescent antibody technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Ability of intratumoral TILs to predict overall survival of these 2 groups of patients [ Designated as safety issue: No ]

Estimated Enrollment: 174
Detailed Description:

OBJECTIVES:

Primary

  • 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.
  • To validate the ability of intratumoral TILs to predict PFS in patients with optimally debulked disease.

Secondary

  • To validate the ability of intratumoral TILs to predict overall survival of patients with suboptimally debulked disease.
  • 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
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of stage III or IV ovarian epithelial cancer and enrolled on 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 t he 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

PATIENT CHARACTERISTICS:

  • Demographic and follow-up data available

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  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

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: George Coukos, MD, PhD Abramson Cancer Center of the University of Pennsylvania
Investigator: Stephen C. Rubin, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01000259     History of Changes
Other Study ID Numbers: CDR0000391277, GOG-8005
Study First Received: October 22, 2009
Last Updated: July 8, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV ovarian epithelial cancer
stage IIIA ovarian epithelial cancer
stage IIIB ovarian epithelial cancer
stage IIIC ovarian epithelial cancer

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

ClinicalTrials.gov processed this record on October 21, 2014