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Completed

NCT Number: NCT00900042

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

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.

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Key information

Conditions

Kidney Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA ploidy analysis

Genetic

DNA stability analysis

Genetic

chromosomal translocation analysis

Genetic

cytogenetic analysis

Genetic

flow cytometry

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1993
Primary completion
2002
Study completion
2003
First posted
May 12, 2009
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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