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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


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
See also
  Status Clinical Trial Phase
Recruiting NCT04322318 - A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT Phase 2
Active, not recruiting NCT00352534 - Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor Phase 3
Not yet recruiting NCT06401330 - A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT) Phase 3
Active, not recruiting NCT00945009 - Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor Phase 3
Active, not recruiting NCT00379340 - Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor Phase 3