Research Study in Patients With Advanced Ovarian Epithelial Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00053235
First received: January 27, 2003
Last updated: May 29, 2015
Last verified: May 2015

January 27, 2003
May 29, 2015
November 2002
August 2010   (final data collection date for primary outcome measure)
  • Association between above chromosomal changes and clinical characteristics [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00053235 on ClinicalTrials.gov Archive Site
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Research Study in Patients With Advanced Ovarian Epithelial Cancer
A Pilot Study to Correlate DNA Sequence Copy Number Abnormalities With Outcome in Patients With Advanced Epithelial Ovarian Cancer

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.

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.

Observational
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Probability Sample
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  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Serous Surface Papillary Adenocarcinoma
  • Stage IIIA Ovarian Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IV Ovarian Cancer
  • Genetic: Comparative Genomic Hybridization
    Correlative studies
    Other Names:
    • CGH
    • Comparative Genome Hybridization
    • Comparative Genomic Analysis
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Genetic: Polymerase Chain Reaction
    Correlative studies
    Other Names:
    • PCR
    • POLYMERASE CHAIN REACTION
Ancillary-Correlative
Genomic DNA is isolated from 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.
Interventions:
  • Genetic: Comparative Genomic Hybridization
  • Other: Laboratory Biomarker Analysis
  • Genetic: Polymerase Chain Reaction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stage III or IV, high-grade (grade 2 or 3) ovarian cancers

    • No borderline or low-grade (grade 1) tumors
    • Tissue from predominately serous ovarian cancer only

      • No clear cell, endometrioid, mucinous, transitional cell, or mixed without predominant serous component
  • Tissue obtained during prior optimal or suboptimal cytoreductive surgery
  • Must be enrolled on GOG-0136 and a GOG front-line paclitaxel/platinum chemotherapy trial
  • Frozen tissue and hematoxylin-eosin stained section from the ovary obtained at initial surgery
  • Performance status - GOG 0-2
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053235
GOG-8004, NCI-2009-00612, CDR0000269315, GOG-8004, GOG-8004
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Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: David Gershenson Gynecologic Oncology Group
Gynecologic Oncology Group
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP