Trial record 1 of 163 for:    "Wilms tumor"
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Gene Analysis in Studying Susceptibility to Wilms Tumor

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01808079
First received: March 6, 2013
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

This clinical trial studies gene analysis in studying susceptibility to Wilms tumor. Finding genetic markers for Wilms tumor may help identify patients who are at risk of relapse


Condition Intervention
Recurrent Wilms Tumor and Other Childhood Kidney Tumors
Stage I Wilms Tumor
Stage II Wilms Tumor
Stage III Wilms Tumor
Stage IV Wilms Tumor
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: OBSERVATIONAL: A Genome-Wide Association Study in Wilms Tumor

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Use a genome-wide association analysis to identify novel genetic variants that confer susceptibility to Wilms tumor [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Genotype 2000 cases using the Illumina Human660W-Quad BeadChip. This will include 1000 UK cases and 1000 US cases. Genotypes will be compared respectively with existing data from 4500 UK controls and 2000 US controls


Secondary Outcome Measures:
  • Improve our understanding of the genetic architecture and etiology of Wilms tumor [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Apply methods which increase power to find rare associated variants, for example by looking for extended haplotypes in subsets of the cases.

  • Facilitate the identification of genetic markers that are associated with an increased risk of developing of Wilms tumor and/or those at risk of aggressive disease, relapse, additional tumors and/or cancer in their offspring. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Compare genotype frequencies between cases and controls at each SNP using the Cochran Armitage trend test. We will also undertake genotypic tests. The data will be analyzed individually for the UK/US study populations and combined using analysis adjusting for study group, and related methods which allow for different effects in each population.


Estimated Enrollment: 4000
Study Start Date: November 2009
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Correlative studies
Samples are analyzed for SNP profiling using real-time PCR and MLPA.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

Study Subtype: Ancillary/Correlative Observational Study Model: Case-control Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: DNA samples Study Population Description: Samples from the National Wilms Tumor Study Group (NWTSG) Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To use a genome-wide association analysis to identify novel genetic variants that confer susceptibility to Wilms tumor.

II. To improve our understanding of the genetic architecture and etiology of Wilms tumor.

III. To facilitate the identification of genetic markers that are associated with an increased risk of developing of Wilms tumor and/or those at risk of aggressive disease, relapse, additional tumors and/or cancer in their offspring.

OUTLINE:

Samples are analyzed for single nucleotide polymorphism (SNP) profiling using real-time polymerase chain reaction (PCR) and multiplex ligation-dependent probe amplification (MLPA).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We currently have 1300 DNA samples from Wilms tumor cases, primarily from recruitment from oncology clinics over the last decade. We are further identifying Wilms tumor survivors > 1000 for targeted recruitment. However, if there is any shortfall, we will use additional US and/or IWTGC cases and we are fully confident that at least 2000 cases for the replication will be available.

Criteria

Inclusion Criteria:

  • 3000 samples from the 1958 Birth Cohort (58C) and 3000 from the UK Blood Service control series (NBS)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01808079

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Paul Grundy Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01808079     History of Changes
Other Study ID Numbers: AREN09B1, NCI-2013-00120, COG-AREN09B1
Study First Received: March 6, 2013
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Wilms Tumor
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 15, 2014