Research Study in Patients With Advanced Ovarian Epithelial Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00053235
First received: January 27, 2003
Last updated: May 29, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Ovarian Serous Cystadenocarcinoma
Ovarian Serous Surface Papillary Adenocarcinoma
Stage IIIA Ovarian Cancer
Stage IIIB Ovarian Cancer
Stage IIIC Ovarian Cancer
Stage IV Ovarian Cancer
Genetic: Comparative Genomic Hybridization
Other: Laboratory Biomarker 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 Gynecologic Oncology Group:

Primary Outcome Measures:
  • Association between above chromosomal changes and clinical characteristics [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients [ Time Frame: baseline ] [ 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 [ Time Frame: baseline ] [ 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) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2002
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Genetic: Comparative Genomic Hybridization
Correlative studies
Other Names:
  • CGH
  • Comparative Genome Hybridization
  • Comparative Genomic Analysis
Other: Laboratory Biomarker Analysis
Correlative studies
Genetic: Polymerase Chain Reaction
Correlative studies
Other Names:
  • PCR
  • POLYMERASE CHAIN REACTION

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Criteria

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

      • 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
  • Performance status - GOG 0-2
  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

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: David Gershenson Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00053235     History of Changes
Other Study ID Numbers: GOG-8004, NCI-2009-00612, CDR0000269315, GOG-8004, GOG-8004
Study First Received: January 27, 2003
Last Updated: May 29, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Papillary
Cystadenocarcinoma
Cystadenocarcinoma, Serous
Ovarian Neoplasms
Adnexal Diseases
Carcinoma
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on August 27, 2015