Biomarkers in Tumor Tissue Samples From Young Patients With Very Low Risk Wilms Tumors - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01004783

Purpose

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial studies biomarkers in tumor tissue samples from young patients with very low risk Wilms tumors.

Condition	Intervention
Kidney Cancer	Genetic: DNA methylation analysis Genetic: gene expression analysis Genetic: loss of heterozygosity analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis

Study Type:	Observational
Official Title:	Validation of Prognostic Markers for Very Low Risk Wilms Tumors

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Kidney Cancer Wilms' Tumor

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Utility of CUGBP2, HMGA2, and MEIS2 mRNA expression and 11p15 methylation to define a population of pediatric patients with very low risk Wilms tumor (VLRWT) that have virtually no risk of relapse [ Designated as safety issue: No ]
Utility of WT-1 mutation and 11p15 loss of heterozygosity analysis to determine a population of VLRWT that have a higher risk of relapse when not treated with chemotherapy [ Designated as safety issue: No ]
Utility of NFYA, STRA6, TOB2, PDCD4, and SP3 mRNA expression to predict relapse in VLRWT [ Designated as safety issue: No ]
Feasibility of broadening the definition of VLRWT through analysis of stage I and II epithelial differentiated tumors registered on clinical trial COG-Q9401 (NWTS-5) for CUGBP2, HMGA2, MEIS2, and 11p15 methylation [ Designated as safety issue: No ]

Estimated Enrollment:	165
Study Start Date:	October 2009
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To validate the utility of CUGBP2, HMGA2, and MEIS2 mRNA expression and 11p15 methylation to define a population of pediatric patients with very low risk Wilms tumor (VLRWT) that have virtually no risk of relapse.
To validate the utility of WT-1 mutation and 11p15 loss of heterozygosity analysis to determine a population of VLRWT that have a higher risk of relapse when not treated with chemotherapy.
To validate the utility of NFYA, STRA6, TOB2, PDCD4, and SP3 mRNA expression to predict relapse in VLRWT.
To investigate the feasibility of broadening the definition of VLRWT through analysis of stage I and II epithelial differentiated tumors registered on clinical trial COG-Q9401 (NWTS-5) for CUGBP2, HMGA2, MEIS2, and 11p15 methylation.

OUTLINE: Previously banked tumor tissue samples are analyzed for mRNA expression of CUGBP2, HMGA2, and MEIS2 via reverse-transcriptase (RT)-PCR and are classified as loss of heterozygosity (LOH), loss of imprinting, or neither via 11p15 analysis. Samples are also analyzed for WT-1 mutation via quantitative PCR and 11p LOH using 11p15 methylation analysis and expression of NFYA, STRA6, TOB2, PDCD4, and SP3 via quantitative RT-PCR

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Meets 1 of the following criteria:
- Patient with very low risk Wilms tumor registered on clinical trial COG-AREN03B2
- Patient with stage I or II epithelial tubular differentiated Wilms tumor registered on clinical trial COG-Q9401 (NWTS-5)

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not Specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004783

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Elizabeth J. Perlman, MD

Children's Memorial Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers:	CDR0000657973, COG-AREN10B1
Study First Received:	October 29, 2009
Last Updated:	January 8, 2010
ClinicalTrials.gov Identifier:	NCT01004783 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I Wilms tumor
stage II Wilms tumor
epithelial predominant Wilms tumor

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma
Neoplasms
Neoplastic Syndromes, Hereditary
Neoplasms by Site
Genetic Diseases, Inborn

Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Wilms Tumor
Kidney Diseases
Adenocarcinoma
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010