SWOG-9023, DNA Analysis of Tumor Tissue From Patients With Metastatic Kidney Cancer

Completed

• Conditions: Kidney Cancer

• Registration Number: NCT00900042
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.

PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from patients with metastatic kidney cancer.

Detailed Description

OBJECTIVES:

* Determine if cytogenetic abnormalities can predict clinical outcome, in terms of response to treatment and survival, in patients with metastatic renal cell carcinoma registered to the nephrectomy arm (arm I) of SWOG-8949.

* Correlate cytogenetic abnormalities and DNA content analysis (DNA index and S-phase fraction) with clinical outcome.

OUTLINE: This is a partially prospective, partially retrospective, multicenter, companion study.

Paraffin-embedded tumor tissue specimens from patients enrolled in SWOG-8949 are evaluated by cytogenetic analysis (e.g., presence of trisomy and loss of Y chromosome) and flow cytometric analysis (e.g., presence of nondiploid cells and presence of abnormal proliferation index).

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Study Timeline

• Study Start: 1993-07
• Primary Completion: 2002-12
• Study Completion: 2003-01
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-21
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of time from first diagnosis of metastatic disease until death with the type and number of abnormalities	up to 4 years after registration	Abnormality is defined as at lease one clonal chromosomal abnormality.
Number of abnormalities per number of successes	up to 4 years after registration	Abnormality is defined as at lease one clonal chromosomal abnormality.
Correlation of time from diagnosis to development of metastatic disease with the type and number of abnormalities	up to 4 years after registration	Abnormality is defined as at lease one clonal chromosomal abnormality.
Correlation of tumor response to treatment with the type and number of abnormalities	up to 4 years after registration	Abnormality is defined as at lease one clonal chromosomal abnormality.
Number of successes per number of evaluable samples	up to 4 years after registration	Success is defined as obtaining at least 10 analyzable metaphases.