Research Study in Patients With Advanced Epithelial Ovarian Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053235
First received: January 27, 2003
Last updated: June 22, 2011
Last verified: March 2007
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Purpose
RATIONALE: Analyzing tissue samples from patients in the laboratory may help doctors learn more about cancer.
PURPOSE: The purpose of this study is to analyze tissue samples from patients with ovarian cancer in the laboratory.
| Condition | Intervention |
|---|---|
|
Ovarian Cancer |
Genetic: comparative genomic hybridization Genetic: cytogenetic analysis Genetic: gene rearrangement analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: polymerase chain reaction |
| Study Type: | Observational |
| Official Title: | A Pilot Study To Correlate DNA Sequence Copy Number Abnormalities With Outcome In Patients With Advanced Epithelial Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- 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 [ Designated as safety issue: No ]
- Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients [ Designated as safety issue: No ]
- Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome [ Designated as safety issue: No ]
- Association between above chromosomal changes and clinical characteristics [ Designated as safety issue: No ]
- Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) [ Designated as safety issue: No ]
| Estimated Enrollment: | 158 |
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 patient samples will be collected for this study.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00053235 History of Changes |
| Other Study ID Numbers: | CDR0000269315, GOG-8004 |
| Study First Received: | January 27, 2003 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IV ovarian epithelial cancer stage IIIA ovarian epithelial cancer stage IIIB ovarian epithelial cancer stage IIIC ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on June 18, 2013