Gene Analysis in Studying Susceptibility to Wilms Tumor

Stage III Kidney Wilms Tumor Clinical Trial

Official title:

A Genome-Wide Association Study in Wilms Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808079
• Other study ID #: AREN09B1
• Secondary ID: NCI-2013-00120AR
• Status: Completed
• Phase: N/A
• First received: March 6, 2013
• Last updated: August 18, 2016
• Start date: October 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

N/A

Related Conditions & MeSH terms

• Kidney Neoplasms
• Neoplasms
• Recurrent Childhood Kidney Neoplasm
• Stage I Kidney Wilms Tumor
• Stage II Kidney Wilms Tumor
• Stage III Kidney Wilms Tumor
• Stage IV Kidney Wilms Tumor
• Wilms Tumor

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Childrens Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequencies between cases and controls at each SNP	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).	Baseline	No
Primary	Frequency of maternal and paternal allelic transmission for risk alleles	Compared using a chi-squared test.	Baseline	No
Primary	Genetic variation on sub-phenotypes such as age at diagnosis, unilateral or bilateral disease, sex, and ethnicity		Baseline	No
Primary	Interactions between genetic variation and treatment success or prognosis		Baseline	No
Primary	Interactions between germline genetic variation and tumor phenotypes		Baseline	No