Research Study in Patients With Advanced Ovarian Epithelial Cancer
NCT ID: NCT00053235
Last Updated: 2015-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2002-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Groups
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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.
Comparative Genomic Hybridization
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
Polymerase Chain Reaction
Correlative studies
Interventions
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Comparative Genomic Hybridization
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
Polymerase Chain Reaction
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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David Gershenson
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NCI-2009-00612
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000269315
Identifier Type: -
Identifier Source: secondary_id
GOG-8004
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-8004
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-8004
Identifier Type: -
Identifier Source: org_study_id
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