NCT01576211

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

4.1 years

First QC Date

April 11, 2012

Last Update Submit

May 17, 2016

Conditions

Keywords

Wilms tumor and other childhood kidney tumors

Outcome Measures

Primary Outcomes (2)

  • Frequency of loss of imprinting at birth

  • Association between methylation levels and gene expression

Interventions

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients registered on Children's Oncology Group Wilms tumor protocols

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

blood and tissue

MeSH Terms

Conditions

Kidney NeoplasmsWilms Tumor

Interventions

DNA MethylationGene Expression ProfilingBase SequenceAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaGenetic TechniquesInvestigative TechniquesMolecular StructureGenetic StructuresDNA FingerprintingPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Karin Michels, MD, PhD

    Dana-Farber/Brigham and Women's Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 12, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05