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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01576211
First received: April 11, 2012
Last updated: April 12, 2012
Last verified: April 2012
History of Changes

April 11, 2012
April 12, 2012
April 2012
June 2012   (final data collection date for primary outcome measure)
  • Frequency of loss of imprinting at birth [ Designated as safety issue: No ]
  • Association between methylation levels and gene expression [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01576211 on ClinicalTrials.gov Archive Site
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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.

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.
Observational
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Kidney Cancer
  • Genetic: DNA methylation analysis
  • Genetic: RNA analysis
  • Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction
  • Genetic: gene expression analysis
  • Genetic: nucleic acid sequencing
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
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June 2012   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01576211
CDR0000730596, COG-AREN12B6
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Peter C. Adamson, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Karin Michels, MD, PhD Dana-Farber/Brigham and Women's Cancer Center
National Cancer Institute (NCI)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP