Clinical trial NCT00053235: 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
Overall status: WITHDRAWN
Conditions: Ovarian Serous Cystadenocarcinoma
Ovarian Serous Surface Papillary Adenocarcinoma
Stage IIIA Ovarian Cancer
Stage IIIB Ovarian Cancer
Stage IIIC Ovarian Cancer
Stage IV Ovarian Cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-28
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE

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.

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

Primary outcomes:
measure: Association between above chromosomal changes and clinical characteristics
timeFrame: baseline
measure: Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients
timeFrame: baseline
measure: Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome
timeFrame: baseline
measure: Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival)
timeFrame: baseline
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 PCR and Taqman analyses
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: David Gershenson
role: PRINCIPAL_INVESTIGATOR
References: