Gene Analysis in Studying Susceptibility to Wilms Tumor

NCT01808079 | Completed

• 2 other identifiers: AREN09B1NCI-2013-00120
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Childhood Kidney Neoplasm; Stage I Kidney Wilms Tumor; Stage II Kidney Wilms Tumor; Stage III Kidney Wilms Tumor; Stage IV Kidney Wilms Tumor

Outcome Measures

Primary Outcomes (5)

• 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

• Frequency of maternal and paternal allelic transmission for risk alleles

  Compared using a chi-squared test.

  Baseline

• Genetic variation on sub-phenotypes such as age at diagnosis, unilateral or bilateral disease, sex, and ethnicity

  Baseline

• Interactions between genetic variation and treatment success or prognosis

  Baseline

• Interactions between germline genetic variation and tumor phenotypes

  Baseline

Study Arms (1)

Ancillary-correlative (genetic markers of Wilms tumor)

Samples are analyzed for SNP profiling using real-time PCR and MLPA.

Other: Laboratory Biomarker Analysis

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-correlative (genetic markers of Wilms tumor)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tissue Bank

You may qualify if:

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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Childrens Oncology Group

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Wilms Tumor

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Paul Grundy

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 11, 2013
• Study Start: October 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 22, 2016

Record last verified: 2016-07

Locations

US (1)