Clinical Trial: Research Study in Patients With Advanced Ovarian Epithelial Cancer

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: A Pilot Study to Correlate DNA Sequence Copy Number Abnormalities With Outcome in Patients With Advanced Epithelial Ovarian Cancer

Brief Summary: This research trial studies tissue samples from patients with ovarian cancer in the laboratory. Analyzing tissue samples from patients in the laboratory may help doctors learn more about cancer.

Detailed Summary:

OBJECTIVES:

I. Utilize array comparative genomic hybridization and Taqman analyses, a quantitative genomic polymerase chain reaction, to validate the observation that a gain in chromosome 8q is predictive of shorter progression-free survival in patients with primary grade 2 or grade 3 advanced serous papillary ovarian cancer.

II. Utilize these analyses to determine whether a gain in chromosome 8q is predictive of worse overall survival in these patients.

III. Utilize these analyses to determine whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome in these patients and the association between these changes and clinical characteristics.

IV. Utilize these analyses to identify up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) in these patients.

OUTLINE:

Genomic DNA is isolated from optimal cutting temperature (OCT)-embedded tissue and analyzed using comparative genomic hybridization. The chromosomal changes identified by this method are compared to those identified using the Taqman method, a quantitative genomic polymerase chain reaction analysis. Chromosome 8q is of specific interest. Other chromosomal changes may be detected in chromosomes 3q, 7q, 16q, and/or 17pter-q21.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

  • Association between above chromosomal changes and clinical characteristics [ Time Frame: baseline ]
  • Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients [ Time Frame: baseline ]
  • Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome [ Time Frame: baseline ]
  • Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) [ Time Frame: baseline ]
  • Validation of the observation that a gain in chromosome 8q is predictive of shorter progression-free survival in patients with primary grade 2 or grade 3 advanced serous papillary ovarian cancer by PCR and Taqman analyses [ Time Frame: baseline ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Gynecologic Oncology Group

Dates:
Date Received: January 27, 2003
Date Started: November 2002
Date Completion:
Last Updated: May 29, 2015
Last Verified: May 2015