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Home > "G" Clinical Trials Conditions > Genetic Study in Patients with Advanced Epithelial Ovarian Cancer  Genetic Study in Patients with Advanced Epithelial Ovarian Cancer
Genetic Study in Patients with Advanced Epithelial Ovarian Cancer
For Condition: stage 4 ovarian epithelial cancer,stage 3 ovarian epithelial cancer
Status: Not yet recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of cancer and may help plan more effective treatment. PURPOSE: Genetic study in patients who have stage III or stage IV ovarian cancer.
Details: 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 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: /
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidGershenson, Study Chair, M.D. Anderson Cancer Center
Additional Information:
Study ID Numbers: CDR0000269315; GOG-8004
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053235
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
2. Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
3. Carboplatin With or Without Liposomal Doxorubicin in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
4. Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
5. Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
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Genetic Study in Patients with Advanced Epithelial Ovarian Cancer
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