SWOG-9023, DNA Analysis of Tumor Tissue From Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00900042|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : February 25, 2014
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.
|Condition or disease||Intervention/treatment|
|Kidney Cancer||Genetic: DNA ploidy analysis Genetic: DNA stability analysis Genetic: chromosomal translocation analysis Genetic: cytogenetic analysis Other: flow cytometry Other: laboratory biomarker analysis|
- 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 Type :||Observational|
|Actual Enrollment :||34 participants|
|Official Title:||Cytogenetic and Flow Cytometric Analysis of : Renal Cell Carcinoma: A Companion Protocol to SWOG-8949|
|Study Start Date :||July 1993|
|Primary Completion Date :||December 2002|
|Study Completion Date :||January 2003|
- Number of successes per number of evaluable samples [ Time Frame: up to 4 years after registration ]Success is defined as obtaining at least 10 analyzable metaphases.
- Number of abnormalities per number of successes [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 4 years after registration ]Abnormality is defined as at lease one clonal chromosomal abnormality.
- Correlation of time from first diagnosis of metastatic disease until death with the type and number of abnormalities [ Time Frame: up to 4 years after registration ]Abnormality is defined as at lease one clonal chromosomal abnormality.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900042
|Study Chair:||Robert P. Whitehead, MD||University of Texas|