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

This study has been completed.
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00837993
First received: February 5, 2009
Last updated: December 20, 2012
Last verified: December 2012

February 5, 2009
December 20, 2012
August 2007
December 2012   (final data collection date for primary outcome measure)
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 ]
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. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00837993 on ClinicalTrials.gov Archive Site
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 ]
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). [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
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Ancillary Study GOG 158: Survival Analysis Based on Reclassification to a Two-Tier Grading System
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

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.

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).

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

Ovarian Cancer
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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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00837993
2007-0509
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Gynecologic Oncology Group
Principal Investigator: Diane C. Bodurka, MD, BS UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP