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Research Study in Patients With Advanced Ovarian Epithelial Cancer

Primary Purpose

Ovarian Serous Cystadenocarcinoma, Ovarian Serous Surface Papillary Adenocarcinoma, Stage IIIA Ovarian Cancer

Status
Withdrawn
Phase
Locations
United States
Study Type
Observational
Intervention
Comparative Genomic Hybridization
Laboratory Biomarker Analysis
Polymerase Chain Reaction
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Ovarian Serous Cystadenocarcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Arm Label

Ancillary-Correlative

Arm Description

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.

Outcomes

Primary Outcome Measures

Association between above chromosomal changes and clinical characteristics
Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients
Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome
Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival)
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

Secondary Outcome Measures

Full Information

First Posted
January 27, 2003
Last Updated
May 29, 2015
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00053235
Brief Title
Research Study in Patients With Advanced Ovarian Epithelial Cancer
Official Title
A Pilot Study to Correlate DNA Sequence Copy Number Abnormalities With Outcome in Patients With Advanced Epithelial Ovarian Cancer
Study Type
Observational

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Study Start Date
November 2002 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Serous Cystadenocarcinoma, Ovarian Serous Surface Papillary Adenocarcinoma, Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer, Stage IV Ovarian Cancer

7. Study Design

Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ancillary-Correlative
Arm Description
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.
Intervention Type
Genetic
Intervention Name(s)
Comparative Genomic Hybridization
Other Intervention Name(s)
CGH, Comparative Genome Hybridization, Comparative Genomic Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Genetic
Intervention Name(s)
Polymerase Chain Reaction
Other Intervention Name(s)
PCR
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Association between above chromosomal changes and clinical characteristics
Time Frame
baseline
Title
Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients
Time Frame
baseline
Title
Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome
Time Frame
baseline
Title
Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival)
Time Frame
baseline
Title
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gershenson
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

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Research Study in Patients With Advanced Ovarian Epithelial Cancer

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