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

NCT ID: NCT01576211

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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DNA methylation analysis

Intervention Type GENETIC

RNA analysis

Intervention Type GENETIC

allele-specific oligonucleotide real-time quantitative polymerase chain reaction

Intervention Type GENETIC

gene expression analysis

Intervention Type GENETIC

nucleic acid sequencing

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karin Michels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber/Brigham and Women's Cancer Center

Other Identifiers

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COG-AREN12B6

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000730596

Identifier Type: OTHER

Identifier Source: secondary_id

AREN12B6

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00726

Identifier Type: REGISTRY

Identifier Source: secondary_id

AREN12B6

Identifier Type: -

Identifier Source: org_study_id

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