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


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Not Enrolling
Female
Ovarian Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

David M. Gershenson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

Unspecified

Study ID:

CDR0000269315

NCT ID:

NCT00053235

Start Date:

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage IV ovarian epithelial cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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