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

NCT ID: NCT00837993

Last Updated: 2012-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Ovarian Cancer

Keywords

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Advanced Stage Serous Carcinoma of the Ovary serous ovarian carcinoma Ovary GOG Protocol 158 Survival Analysis Pathology Slides Two-tier Grading System Ancillary Study

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gynecologic Oncology Group

NETWORK

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diane C. Bodurka, MD, BS

Role: PRINCIPAL_INVESTIGATOR

UT MD Anderson Cancer Center

Locations

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UT MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Rose PG, Java JJ, Salani R, Geller MA, Secord AA, Tewari KS, Bender DP, Mutch DG, Friedlander ML, Van Le L, Method MW, Hamilton CA, Lee RB, Wenham RM, Guntupalli SR, Markman M, Muggia FM, Armstrong DK, Bookman MA, Burger RA, Copeland LJ. Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma. Obstet Gynecol. 2019 Feb;133(2):245-254. doi: 10.1097/AOG.0000000000003086.

Reference Type DERIVED
PMID: 30633128 (View on PubMed)

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center

Other Identifiers

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2007-0509

Identifier Type: -

Identifier Source: org_study_id