Research Study in Patients With Advanced Ovarian Epithelial Cancer

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Stage IIIA Ovarian Cancer, Ovarian Serous Cystadenocarcinoma, Ovarian Serous Surface Papillary Adenocarcinoma, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer, Stage IV Ovarian Cancer

Intervention / Treatment
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* Genetic: Comparative Genomic Hybridization
* Other: Laboratory Biomarker Analysis
* Genetic: Polymerase Chain Reaction


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative<br>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. | Genetic: Comparative Genomic Hybridization<br>* Correlative studies<br>* Other names: Comparative Genomic Analysis;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Genetic: Polymerase Chain Reaction<br>* Correlative studies<br>* Other names: PCR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between above chromosomal changes and clinical characteristics |  | baseline | 
| Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients |  | baseline | 
| Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome |  | baseline | 
| Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) |  | 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 |  | baseline |