NCT00053235

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

7.8 years

First QC Date

January 27, 2003

Last Update Submit

May 29, 2015

Conditions

Ovarian Serous CystadenocarcinomaOvarian Serous Surface Papillary AdenocarcinomaStage IIIA Ovarian CancerStage IIIB Ovarian CancerStage IIIC Ovarian CancerStage IV Ovarian Cancer

Outcome Measures

Primary Outcomes (5)

  • Association between above chromosomal changes and clinical characteristics

    baseline

  • Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients

    baseline

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

    baseline

  • Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival)

    baseline

  • 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

Study Arms (1)

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 HybridizationOther: Laboratory Biomarker AnalysisGenetic: Polymerase Chain Reaction

Interventions

Comparative Genomic HybridizationGENETIC

Correlative studies

Also known as: CGH, Comparative Genome Hybridization, Comparative Genomic Analysis
Ancillary-Correlative
Laboratory Biomarker AnalysisOTHER

Correlative studies

Ancillary-Correlative
Polymerase Chain ReactionGENETIC

Correlative studies

Also known as: PCR
Ancillary-Correlative

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Comparative Genomic HybridizationPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Cytogenetic AnalysisGenetic TechniquesInvestigative TechniquesMolecular Diagnostic TechniquesNucleic Acid HybridizationNucleic Acid Amplification Techniques

Study Officials

  • David Gershenson

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2003

First Posted

January 28, 2003

Study Start

November 1, 2002

Primary Completion

August 1, 2010

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

US(1)