Research Study in Patients With Advanced Epithelial Ovarian Cancer - Full Text View

Sponsors and Collaborators:	Gynecologic Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00053235

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:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

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

Detailed Description:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053235

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

David M. Gershenson, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000269315, GOG-8004
Study First Received:	January 27, 2003
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00053235 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Ovarian Cancer
Endocrine System Diseases

Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Ovarian Epithelial Cancer
Congenital Abnormalities
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009