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
Recruitment status was Active, not recruiting
Sponsor:
Gynecologic Oncology Group
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
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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 |
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
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:
|
Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013