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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01576211
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : May 18, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief 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.

Condition or disease Intervention/treatment
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

Detailed Description:


  • 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
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Investigating the Frequency of Loss of Imprinting Across a Birth Cohort and the Link DNA Methylation Plays
Study Start Date : April 2012
Actual Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Frequency of loss of imprinting at birth
  2. Association between methylation levels and gene expression

Biospecimen Retention:   Samples With DNA
blood and tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients registered on Children's Oncology Group Wilms tumor protocols


  • 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


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01576211

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

Responsible Party: Children's Oncology Group Identifier: NCT01576211     History of Changes
Other Study ID Numbers: AREN12B6
COG-AREN12B6 ( Other Identifier: Children's Oncology Group )
CDR0000730596 ( Other Identifier: Clinical )
AREN12B6 ( Other Identifier: Children's Oncology Group )
NCI-2012-00726 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
Wilms tumor and other childhood kidney tumors

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