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

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00837993
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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).

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-20
• Last Update Posted: 2012-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 241

Inclusion Criteria

• All patients enrolled on GOG protocol 158 with a diagnosis of serous carcinoma of the ovary.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

UT MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States