Studying Genes Using Cord Blood and Placenta Samples From Relatively Healthy Newborns and Samples From Younger Patients With Wilms Tumor

Investigating the Frequency of Loss of Imprinting Across a Birth Cohort and the Link DNA Methylation Plays

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

PURPOSE: This research trial studies cord blood and placenta tissue from newborns, and tumor tissue samples from patients with Wilms tumor.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer
• Intervention / Treatment: Genetic: gene expression analysis; Genetic: polymorphism analysis; Other: laboratory biomarker analysis; Genetic: DNA methylation analysis; Genetic: RNA analysis; Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction; Genetic: nucleic acid sequencing

Detailed Description

OBJECTIVES:

• What is the frequency of loss of imprinting at birth (in the cord blood and placenta) in a relatively healthy birth cohort?
• Does deoxyribonucleic acid (DNA) methylation levels at imprinting genes have a direct association to the gene expression?

OUTLINE: Archived tumor tissue, cord blood, and placenta samples are analyzed for DNA methylation, single nucleotide polymorphism, and gene expression by polymerase chain reaction (PCR), pyrosequencing, and quantitative real-time PCR. Information regarding gender and age of the samples are also collected, if possible.

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients registered on Children's Oncology Group Wilms tumor protocols

Description

DISEASE CHARACTERISTICS:

• Wilms tumor tissue samples from Caucasians (fresh or frozen), or DNA and ribonucleic acid (RNA) samples already isolated from patients registered on Children's Oncology Group Wilms tumor protocols
• Normal/control blood samples from matched individuals
• Cord blood/ placenta samples from the Michels lab Epigenetic Birth Cohort

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Frequency of loss of imprinting at birth
Association between methylation levels and gene expression

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Karin Michels, MD, PhD, Dana-Farber/Brigham and Women's Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 11, 2012
• First Submitted That Met QC Criteria: April 11, 2012
• First Posted (Estimate): April 12, 2012

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Wilms tumor and other childhood kidney tumors
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary; Neoplasms, Complex and Mixed; Kidney Neoplasms; Wilms Tumor
• Other Study ID Numbers: AREN12B6 (Other Identifier: Children's Oncology Group); COG-AREN12B6 (Other Identifier: Children's Oncology Group); CDR0000730596 (Other Identifier: Clinical Trials.gov); NCI-2012-00726 (Registry Identifier: CTRP (Clinical Trial Reporting Program))