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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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00053235
Enrollment
0
Registered
2003-01-28
Start date
2002-11-30
Completion date
Unknown
Last updated
2015-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

GENETICComparative Genomic Hybridization

Correlative studies

OTHERLaboratory Biomarker Analysis

Correlative studies

GENETICPolymerase Chain Reaction

Correlative studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Association between above chromosomal changes and clinical characteristicsbaseline
Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patientsbaseline
Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcomebaseline
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 analysesbaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026