Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01576198
First received: April 11, 2012
Last updated: April 21, 2012
Last verified: April 2012
  Purpose

RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.


Condition Intervention
Kidney Cancer
Genetic: DNA analysis
Genetic: nucleic acid amplification
Other: diagnostic laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Official Title: Validation of Copy Number Changes by MLPA as Predictors of Relapse in Wilms Tumor

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Validation of copy number changes (gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q) in FHWT by the MLPA assay [ Designated as safety issue: No ]

Estimated Enrollment: 2227
Study Start Date: April 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To analyze 250 favorable-histology Wilms tumor (FHWT) samples from patients registered on NWTS4 for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by subtelomeric multiplex ligation-dependent probe amplification (MLPA), and to determine their association with relapse-free and overall survival.
  • To develop a robust multiplex MLPA test using multiple synthesized probes to those targets identified as significantly associated with relapse in Aim 1.
  • To validate the multiplex MLPA test designed and tested in Aim 2 on an independent set of 1727 FHWT and 250 anaplastic WT registered on NWTS-5.

OUTLINE: Archived DNA samples are analyzed for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by MLPA. Assay results are then researched for accuracy, clinical validity, sensitivity, precision, and potential analytical interferences.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • DNA samples from FHWT patients registered on:

    • NWTS-4
    • NWTS-5 with focal and diffuse anaplasia tumors

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576198

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Elizabeth J. Perlman, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01576198     History of Changes
Other Study ID Numbers: CDR0000730403, COG-AREN11B3
Study First Received: April 11, 2012
Last Updated: April 21, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Wilms tumor and other childhood kidney tumors

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Wilms Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 28, 2014