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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576211
• Other study ID #: AREN12B6
• Secondary ID: COG-AREN12B6CDR0
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: May 17, 2016
• Start date: April 2012

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Cancer

Intervention

Genetic:
• DNA methylation analysis

• RNA analysis

• allele-specific oligonucleotide real-time quantitative polymerase chain reaction

• gene expression analysis

• nucleic acid sequencing

• polymorphism analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of loss of imprinting at birth			No
Primary	Association between methylation levels and gene expression			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database