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Observational Study of Ovarian Cancer Tissue Samples

This research study is looking at tumor tissue samples from women who have had surgery for advanced stage III or stage IV ovarian epithelial cancer. Researchers will analyze these samples to understand how certain immune cells, called tumor-infiltrating T lymphocytes (TILs), might predict how well patients respond to treatment and how long they live. This study aims to validate if TILs can predict progression-free survival (how long you live without the cancer getting worse) and overall survival (how long you live). The study involves analyzing samples that were collected in previous Gynecologic Oncology Group (GOG) trials.

Study design
This is an observational study with a planned enrollment of 174 participants. It involves analyzing previously collected tissue samples.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures overall survival and progression-free survival curves at baseline, but does not specify follow-up duration.

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NCT01000259

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

Recruiting
Not specifiedAll AgesObservational
Gynecologic Oncology Group
~174 participants
Updated 2017-05-05 on ClinicalTrials.gov
What's tested:Laboratory Biomarker Analysis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival curves
Measured over Baseline
+1 more outcome measured

Conditions

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

Explore related trials

Malignant Ovarian Neoplasm

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • George Coukos · PRINCIPAL_INVESTIGATOR · Gynecologic Oncology Group

Who to contact

George Coukos
[email protected]
215-662-3316
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Eligibility criteria

Inclusion

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

What this trial measures

  • Overall survival curvesBaseline

    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 curvesBaseline

    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.