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Research Study in Patients With Advanced Ovarian Epithelial Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00053235
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Genetic: Comparative Genomic Hybridization
  • Other: Laboratory Biomarker Analysis
  • Genetic: Polymerase Chain Reaction

Detailed Description

OBJECTIVES:

  1. 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.

  2. Utilize these analyses to determine whether a gain in chromosome 8q is predictive of worse overall survival in these patients.

  3. 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.

  4. 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.

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Official Title:
A Pilot Study to Correlate DNA Sequence Copy Number Abnormalities With Outcome in Patients With Advanced Epithelial Ovarian Cancer
Study Start Date :
Nov 1, 2002
Actual Primary Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Association between above chromosomal changes and clinical characteristics [baseline]

    2. Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients [baseline]

    3. Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome [baseline]

    4. Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) [baseline]

    5. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Gynecologic Oncology Group Philadelphia Pennsylvania United States 19103

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: David Gershenson, Gynecologic Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynecologic Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00053235
    Other Study ID Numbers:
    • GOG-8004
    • NCI-2009-00612
    • CDR0000269315
    • GOG-8004
    • GOG-8004
    First Posted:
    Jan 28, 2003
    Last Update Posted:
    Jun 1, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Cystadenocarcinoma
    Cystadenocarcinoma, Serous
    Adenocarcinoma, Papillary

    Study Results

    No Results Posted as of Jun 1, 2015