Research Study in Patients With Advanced Ovarian Epithelial Cancer

Stage IV Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00053235
• Other study ID #: GOG-8004
• Secondary ID: NCI-2009-00612CD
• Status: Withdrawn
• Phase: N/A
• First received: January 27, 2003
• Last updated: May 29, 2015
• Start date: November 2002

Study information

• Verified date: May 2015
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Papillary
• Cystadenocarcinoma
• Ovarian Neoplasms
• Ovarian Serous Cystadenocarcinoma
• Ovarian Serous Surface Papillary Adenocarcinoma
• Stage IIIA Ovarian Cancer
• Stage IIIB Ovarian Cancer
• Stage IIIC Ovarian Cancer
• Stage IV Ovarian Cancer

Intervention

Genetic:
• Comparative Genomic Hybridization
Correlative studies

Other:
• Laboratory Biomarker Analysis
Correlative studies

Genetic:
• Polymerase Chain Reaction
Correlative studies

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between above chromosomal changes and clinical characteristics		baseline	No
Primary	Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients		baseline	No
Primary	Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome		baseline	No
Primary	Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival)		baseline	No
Primary	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	No