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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cytogenetic and Flow Cytometric Analysis of : Renal Cell Carcinoma: A Companion Protocol to SWOG-8949

Conditions
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Kidney Cancer

Intervention / Treatment
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* Genetic: DNA ploidy analysis
* Genetic: DNA stability analysis
* Genetic: chromosomal translocation analysis
* Genetic: cytogenetic analysis
* Other: flow cytometry
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of renal cell carcinoma Any T, any N, M1 disease as specified in SWOG-8949 Eligible for and registered on the nephrectomy arm* (arm I) of SWOG-8949 NOTE: *Patients must be registered on this study before undergoing nephrectomy on SWOG-8949 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA ploidy analysis|nan|
|Genetic: DNA stability analysis|nan|
|Genetic: chromosomal translocation analysis|nan|
|Genetic: cytogenetic analysis|nan|
|Other: flow cytometry|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer