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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00612 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000269315 | |||
| GOG-8004 | Other Identifier | Gynecologic Oncology Group | |
| GOG-8004 | Other Identifier | CTEP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparative Genomic Hybridization | Genetic | Correlative studies |
|
| 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 |
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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
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
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| Name | Affiliation | Role |
|---|---|---|
| David Gershenson | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Polymerase Chain Reaction | Genetic | Correlative studies |
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|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D055028 | Comparative Genomic Hybridization |
| D016133 | Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D025202 | Molecular Diagnostic Techniques |
| D009693 | Nucleic Acid Hybridization |
| D021141 | Nucleic Acid Amplification Techniques |
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