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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00900042

Enrollment

Registered

2009-05-12

Start date

1993-07-31

Completion date

2003-01-31

Last updated

2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

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.

Interventions

GENETICDNA ploidy analysis

GENETICDNA stability analysis

GENETICchromosomal translocation analysis

GENETICcytogenetic analysis

OTHERflow cytometry

OTHERlaboratory biomarker analysis

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Number of successes per number of evaluable samples	up to 4 years after registration	Success is defined as obtaining at least 10 analyzable metaphases.
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 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.
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 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026