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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


N/A
N/A
N/A
Not Enrolling
Female
Ovarian Cancer

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Trial Information

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


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).


Inclusion Criteria:



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

Exclusion Criteria:

- None

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

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.

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Diane C. Bodurka, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0509

NCT ID:

NCT00837993

Start Date:

August 2007

Completion Date:

December 2012

Related Keywords:

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

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030