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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01576211
First received: April 11, 2012
Last updated: May 17, 2016
Last verified: May 2016
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Frequency of loss of imprinting at birth [ Designated as safety issue: No ]
  • Association between methylation levels and gene expression [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
blood and tissue

Estimated Enrollment: 40
Study Start Date: April 2012
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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
  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: NCT01576211

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

Additional Information:
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01576211     History of Changes
Other Study ID Numbers: AREN12B6  COG-AREN12B6  CDR0000730596  AREN12B6  NCI-2012-00726 
Study First Received: April 11, 2012
Last Updated: May 17, 2016
Health Authority: United States: Federal Government

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
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 26, 2016