Ancillary Study GOG 158: Survival Analysis Based on Reclassification to a Two-Tier Grading System

Study Overview
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Brief Summary
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Primary Objective: To reclassify the histologic grade of the serous ovarian cancer specimens of patients enrolled on Gynecologic Oncology Group (GOG) protocol 158 using a two-tier system. Secondary Objective: To determine the overall and progression-free survival of patients with serous carcinoma of the ovary treated on GOG protocol 158 when reclassified according to tumor grade (low vs. high). Tertiary Objective: To correlate histologic grade with other prognostic factors.

Detailed Description
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The purpose of this study is to describe the progression-free and overall survival of patients treated on GOG protocol 158 when their tumors are reclassified into a two-tier grading system. Although no universal grading system exists, Malpica et al. have recently published data on a clinically meaningful two-tier grading system for serous ovarian carcinoma (Malpica et al., American Journal of Surgical Pathology, 2004). Tumor grade has been shown to be an important prognostic factor in women with epithelial ovarian cancer, especially in early stage carcinomas. While there is less consensus regarding the prognostic significance of grade in late stage tumors, researchers have noted that patients with low-grade advanced disease may have a longer survival than those with high-grade lesions (Bodurka-Bevers et al., Gynecologic Oncology, 2000).

Official Title
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An Ancillary Study of Patients With Advanced Stage Serous Carcinoma of the Ovary Treated on GOG Protocol 158: A Survival Analysis Based on Reclassification to a Two-tier Grading System

Conditions
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Ovarian Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients enrolled on GOG protocol 158 with a diagnosis of serous carcinoma of the ovary. Exclusion Criteria: None
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survival Analysis<br>Survival Analysis Based on Reclassification to a Two-tier Grading System: Review of Pathology Slides for Patients participating on Protocol COG 158. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reclassification of histologic grade of the serous ovarian cancer specimens of patients enrolled on Gynecologic Oncology Group (GOG) protocol 158 using a two-tier system. |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall and Progression-free survival of patients with serous carcinoma of the ovary treated on GOG protocol 158 when reclassified according to tumor grade (low vs. high) |  | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Stage Serous Carcinoma of the Ovary, serous ovarian carcinoma, Ovary, GOG Protocol 158, Survival Analysis, Pathology Slides, Two-tier Grading System, Ancillary Study