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
Sponsor:
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: David M. Gershenson, MD M.D. Anderson Cancer Center
  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 August 28, 2014