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Gene Analysis in Studying Susceptibility to Wilms Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01808079
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : August 22, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
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 or disease Intervention/treatment
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

Detailed Description:


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.


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

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Study Type : Observational
Actual Enrollment : 1 participants
Official Title: A Genome-Wide Association Study in Wilms Tumor
Study Start Date : October 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Wilms Tumor

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Frequencies between cases and controls at each SNP [ Time Frame: Baseline ]
    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).

  2. Frequency of maternal and paternal allelic transmission for risk alleles [ Time Frame: Baseline ]
    Compared using a chi-squared test.

  3. Genetic variation on sub-phenotypes such as age at diagnosis, unilateral or bilateral disease, sex, and ethnicity [ Time Frame: Baseline ]
  4. Interactions between genetic variation and treatment success or prognosis [ Time Frame: Baseline ]
  5. Interactions between germline genetic variation and tumor phenotypes [ Time Frame: Baseline ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tissue Bank

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01808079

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United States, Pennsylvania
Childrens Oncology Group
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
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Principal Investigator: Paul Grundy Children's Oncology Group
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Responsible Party: Children's Oncology Group Identifier: NCT01808079    
Other Study ID Numbers: AREN09B1
NCI-2013-00120 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AREN09B1 ( Other Identifier: Childrens Oncology Group )
AREN09B1 ( Other Identifier: CTEP )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Wilms Tumor
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