Gene Analysis in Studying Susceptibility to Wilms Tumor
|ClinicalTrials.gov Identifier: NCT01808079|
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : August 22, 2016
|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|
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).
|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|
Ancillary-correlative (genetic markers of Wilms tumor)
Samples are analyzed for SNP profiling using real-time PCR and MLPA.
Other: Laboratory Biomarker Analysis
- 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).
- Frequency of maternal and paternal allelic transmission for risk alleles [ Time Frame: Baseline ]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 ]
- Interactions between genetic variation and treatment success or prognosis [ Time Frame: Baseline ]
- Interactions between germline genetic variation and tumor phenotypes [ Time Frame: Baseline ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808079
|United States, Pennsylvania|
|Childrens Oncology Group|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Paul Grundy||Children's Oncology Group|