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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00900042
First received: May 9, 2009
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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 Intervention
Kidney Cancer
Genetic: DNA ploidy analysis
Genetic: DNA stability analysis
Genetic: chromosomal translocation analysis
Genetic: cytogenetic analysis
Other: flow cytometry
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cytogenetic and Flow Cytometric Analysis of : Renal Cell Carcinoma: A Companion Protocol to SWOG-8949

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Number of successes per number of evaluable samples [ Time Frame: up to 4 years after registration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Abnormality is defined as at lease one clonal chromosomal abnormality.


Biospecimen Retention:   Samples With DNA

Tumor diagnostic tissue


Enrollment: 34
Study Start Date: July 1993
Study Completion Date: January 2003
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900042

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Robert P. Whitehead, MD University of Texas
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00900042     History of Changes
Other Study ID Numbers: CDR0000502305, SWOG-9023, U10CA032102
Study First Received: May 9, 2009
Last Updated: February 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 01, 2014