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Research Study to Correlate DNA Sequence Copy Number Abnormalities With Outcome in Patients With Advanced Epithelial Ovarian Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Research Study in Patients with Advanced Epithelial Ovarian Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Biomarker/Laboratory analysis | Approved-not yet active | Any age | GOG-8004
NCT00053235 |
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.
Entry Criteria 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - See Disease Characteristics
Endocrine therapy Radiotherapy Surgery - See Disease Characteristics
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal Expected Enrollment 158A total of 158 patient samples will be collected for this study. Outcomes Primary Outcome(s)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
Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients
Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome
Association between above chromosomal changes and clinical characteristics
Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival)
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.
Trial Contact Information
Trial Lead Organizations Gynecologic Oncology Group | | | | David Gershenson, MD, Protocol chair | | | Ph: 713-745-2565; 800-392-1611 |
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| Registry Information | | | Official Title | | A Pilot Study To Correlate DNA Sequence Copy Number Abnormalities With Outcome In Patients With Advanced Epithelial Ovarian Cancer | | | Registered in ClinicalTrials.gov | | NCT00053235 | | | Date Submitted to PDQ | | 2002-11-20 | | | Information Last Verified | | 2007-03-08 |
Note: The purpose of some clinical studies is to help researchers learn more about how cancer cells grow and how drugs are used in the body. Cells and tissues collected from cancer patients may be used to detect new biomarkers that may be important in diagnosing and treating cancer in the future. The procedure or lab test described in this clinical study is intended to be carried out by clinical oncologists and researchers in carefully structured settings. Individual results obtained from these studies may not be made available to patients.  Back to Top |
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