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Gene Analysis in Studying Susceptibility to Wilms Tumor

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01808079
First received: March 6, 2013
Last updated: August 18, 2016
Last verified: July 2016
  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 Childhood Kidney Neoplasm
Stage I Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
Other: Laboratory Biomarker Analysis

Study Type: Observational
Official Title: 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:
  • Frequencies between cases and controls at each SNP [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Compared using the Cochran Armitage trend test (1-df). The data will be analyzed individually for the UK/US study populations and combined using a Mantel-Haenszel analysis adjusting for study group, and related methods which allow for different effects in each population (for confirmed loci, we will compare effects across populations).

  • Frequency of maternal and paternal allelic transmission for risk alleles [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Compared using a chi-squared test.

  • Genetic variation on sub-phenotypes such as age at diagnosis, unilateral or bilateral disease, sex, and ethnicity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Interactions between genetic variation and treatment success or prognosis [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Interactions between germline genetic variation and tumor phenotypes [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-correlative (genetic markers of Wilms tumor)
Samples are analyzed for SNP profiling using real-time PCR and MLPA.
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tissue Bank
Criteria

Inclusion Criteria:

  • 3000 samples from the 1958 Birth Cohort (58C) and 3000 from the UK Blood Service control series (NBS)
  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: NCT01808079

Locations
United States, Pennsylvania
Childrens Oncology Group
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Paul Grundy Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01808079     History of Changes
Other Study ID Numbers: AREN09B1  NCI-2013-00120  AREN09B1  AREN09B1 
Study First Received: March 6, 2013
Last Updated: August 18, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 02, 2016