Research Study in Patients With Advanced Epithelial Ovarian Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053235
First received: January 27, 2003
Last updated: June 22, 2011
Last verified: March 2007

January 27, 2003
June 22, 2011
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  • 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 microarray and Taqman analyses [ Designated as safety issue: No ]
  • Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients [ 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 [ Designated as safety issue: No ]
  • Association between above chromosomal changes and clinical characteristics [ 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) [ 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 Epithelial Ovarian Cancer
A Pilot Study To Correlate DNA Sequence Copy Number Abnormalities With Outcome In Patients With Advanced Epithelial Ovarian Cancer

RATIONALE: Analyzing tissue samples from patients in the laboratory may help doctors learn more about cancer.

PURPOSE: The purpose of this study is to analyze tissue samples from patients with ovarian cancer in the laboratory.

OBJECTIVES:

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

PROJECTED ACCRUAL: A total of 158 patient samples will be collected for this study.

Observational
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Ovarian Cancer
  • Genetic: comparative genomic hybridization
  • Genetic: cytogenetic analysis
  • Genetic: gene rearrangement analysis
  • Genetic: microarray analysis
  • Genetic: mutation 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.
 
Not yet recruiting
158
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
Female
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No
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NCT00053235
CDR0000269315, GOG-8004
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: David M. Gershenson, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
March 2007

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