Ancillary Study GOG 158: Survival Analysis Based on Reclassification to a Two-Tier Grading System
- 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.
- 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).
- To correlate histologic grade with other prognostic factors.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||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|
- 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. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- 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) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Survival Analysis Based on Reclassification to a Two-tier Grading System: Review of Pathology Slides for Patients participating on Protocol COG 158.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837993
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Diane C. Bodurka, MD, BS||UT MD Anderson Cancer Center|