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:

National Cancer Institute (NCI)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 27, 2003

Last Updated Date

June 22, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00053235 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Research Study in Patients With Advanced Epithelial Ovarian Cancer

Official Title ^ICMJE

A Pilot Study To Correlate DNA Sequence Copy Number Abnormalities With Outcome In Patients With Advanced Epithelial Ovarian Cancer

Brief Summary

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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Genetic: comparative genomic hybridization
Genetic: cytogenetic analysis
Genetic: gene rearrangement analysis
Genetic: microarray analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

158

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00053235

Other Study ID Numbers ^ICMJE

CDR0000269315, GOG-8004

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

David M. Gershenson, MD

M.D. Anderson Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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