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:

National Cancer Institute (NCI)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 22, 2009

Last Updated Date

July 8, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01000259 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Validation Of Tumor-Infiltrating T-Cells As A Biomarker For Advanced Epithelial Ovarian Cancer

Brief Summary

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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Other: fluorescent antibody technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

174

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01000259

Other Study ID Numbers ^ICMJE

CDR0000391277, GOG-8005

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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