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
  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
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Survival Analysis
Survival Analysis Based on Reclassification to a Two-tier Grading System: Review of Pathology Slides for Patients participating on Protocol COG 158.

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
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837993

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Gynecologic Oncology Group
Investigators
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 July 22, 2014