Ancillary Study GOG 158: Survival Analysis Based on Reclassification to a Two-Tier Grading System
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Purpose
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.
| Condition |
|---|
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Ovarian Cancer |
| Study Type: | Observational |
| 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 ]
| Enrollment: | 241 |
| Study Start Date: | August 2007 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Survival Analysis
Survival Analysis Based on Reclassification to a Two-tier Grading System: Review of Pathology Slides for Patients participating on Protocol COG 158.
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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).
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All patients enrolled on GOG protocol 158 with a diagnosis of serous carcinoma of the ovary.
Inclusion Criteria:
- All patients enrolled on GOG protocol 158 with a diagnosis of serous carcinoma of the ovary.
Exclusion Criteria:
- None
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00837993 History of Changes |
| Other Study ID Numbers: | 2007-0509 |
| Study First Received: | February 5, 2009 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Stage Serous Carcinoma of the Ovary serous ovarian carcinoma Ovary GOG Protocol 158 |
Survival Analysis Pathology Slides Two-tier Grading System Ancillary Study |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Cystadenocarcinoma, Serous Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Cystadenocarcinoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous |
ClinicalTrials.gov processed this record on May 23, 2013