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

NCT ID: NCT01000259

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stage IIIA Ovarian Cancer Stage IIIB Ovarian Cancer Stage IIIC Ovarian Cancer Stage IV Ovarian Cancer

Study Groups

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Ancillary-Correlative

Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining.

Laboratory Biomarker Analysis

Intervention Type OTHER

Samples are analyzed in laboratory studies

Interventions

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Laboratory Biomarker Analysis

Samples are analyzed in laboratory studies

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Coukos

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

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Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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George Coukos

Role: primary

215-662-3316

Other Identifiers

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NCI-2011-02279

Identifier Type: REGISTRY

Identifier Source: secondary_id

GOG-8005

Identifier Type: -

Identifier Source: secondary_id

CDR0000391277

Identifier Type: -

Identifier Source: secondary_id

GOG-8005

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-8005

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-8005

Identifier Type: -

Identifier Source: org_study_id

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