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

December 20, 2012 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Survival Analysis
Survival Analysis Based on Reclassification to a Two-tier Grading System: Review of Pathology Slides for Patients participating on Protocol COG 158.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Gynecologic Oncology Group

Investigators

  • Principal Investigator: Diane C. Bodurka, MD, BS, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

December 21, 2012

Last Update Submitted That Met QC Criteria

December 20, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2007-0509

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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