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CompletedNCT01576211Updated May 18, 2016

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

An observational study in Kidney Cancer, sponsored by Children's Oncology Group. Completed. Open to participants aged Up to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
40
Ages
Up to 21 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Kidney Cancer

Keywords

  • Wilms tumor and other childhood kidney tumors
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In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's planned enrollment of 40 is below the median of 218 across 216 observational studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients registered on Children's Oncology Group Wilms tumor protocols

Eligibility 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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • GeneticDNA methylation analysis
  • GeneticRNA analysis
  • Geneticallele-specific oligonucleotide real-time quantitative polymerase chain reaction
  • Geneticgene expression analysis
  • Geneticnucleic acid sequencing
  • Geneticpolymorphism analysis
  • Otherlaboratory biomarker analysis
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What researchers measure

Primary outcomes

  1. Frequency of loss of imprinting at birth

  2. Association between methylation levels and gene expression

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01576211
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 12, 2012
Start date
Apr 2012
Primary completion
May 2016
Last update
May 18, 2016

Study contacts

Karin Michels, MD, PhD
principal investigator · Dana-Farber/Brigham and Women's Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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