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CompletedNCT00900042Updated Feb 25, 2014

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

An observational study in Kidney Cancer, sponsored by SWOG Cancer Research Network. Completed. Per ClinicalTrials.gov, last updated 2014-02-25.

Sponsored by SWOG Cancer Research Network · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
34
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Kidney Cancer

Keywords

  • stage IV renal cell cancer
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In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's enrollment of 34 is below the median of 218 across 216 observational studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
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Study design

Time perspective
Prospective
Enrollment
34 participants (actual)
Biospecimen retention
Samples with dna

Interventions

  • GeneticDNA ploidy analysis
  • GeneticDNA stability analysis
  • Geneticchromosomal translocation analysis
  • Geneticcytogenetic analysis
  • Otherflow cytometry
  • Otherlaboratory biomarker analysis
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What researchers measure

Primary outcomes

  1. Number of successes per number of evaluable samples

    Success is defined as obtaining at least 10 analyzable metaphases.

    Time frame: up to 4 years after registration

  2. Number of abnormalities per number of successes

    Abnormality is defined as at lease one clonal chromosomal abnormality.

    Time frame: up to 4 years after registration

  3. Correlation of tumor response to treatment with the type and number of abnormalities

    Abnormality is defined as at lease one clonal chromosomal abnormality.

    Time frame: up to 4 years after registration

  4. 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.

    Time frame: up to 4 years after registration

  5. 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.

    Time frame: up to 4 years after registration

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00900042
Lead sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Jul 1993
Primary completion
Dec 2002
Completion
Jan 2003
Last update
Feb 25, 2014

Study contacts

Robert P. Whitehead, MD
study chair · University of Texas
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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