NCT01118078

Brief Summary

This research study is studying biomarkers in tissue samples from patients with high-risk Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

6 years

First QC Date

May 5, 2010

Last Update Submit

May 17, 2016

Conditions

Clear Cell Sarcoma of the KidneyRecurrent Wilms Tumor and Other Childhood Kidney TumorsRhabdoid Tumor of the KidneyStage I Wilms TumorStage II Wilms TumorStage III Wilms TumorStage IV Wilms TumorStage V Wilms Tumor

Outcome Measures

Primary Outcomes (3)

  • Genomic gains and losses in high-risk Wilms tumor

    After completion of biomarker analysis

  • Transcription patterns involved in the pathogenesis of Wilms tumor

    After completion of biomarker analysis

  • Genetic mutations involved in the pathogenesis of Wilms tumor

    After completion of biomarker analysis

Study Arms (1)

Biomarker (DNA methylation, gene expression, RT-PCR)

Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression analysis, DNA methylation, and genomic re-sequencing by microarray analysis-based methods, including PCR analysis, DNA methylation analysis-specific RT-PCR, and quantitative RT-PCR (reverse transcriptase-polymerase chain reaction)

Genetic: DNA methylation analysisGenetic: gene expression analysisGenetic: microarray analysisGenetic: reverse transcriptase-polymerase chain reactionOther: diagnostic laboratory biomarker analysis

Interventions

DNA methylation analysisGENETIC

Undergo DNA methylation analysis

Biomarker (DNA methylation, gene expression, RT-PCR)
gene expression analysisGENETIC

Undergo gene expression analysis

Biomarker (DNA methylation, gene expression, RT-PCR)
microarray analysisGENETIC

Undergo microarray analysis

Also known as: gene expression profiling
Biomarker (DNA methylation, gene expression, RT-PCR)
reverse transcriptase-polymerase chain reactionGENETIC

Undergo RT-PCR

Also known as: RT-PCR
Biomarker (DNA methylation, gene expression, RT-PCR)
diagnostic laboratory biomarker analysisOTHER

Correlative studies

Biomarker (DNA methylation, gene expression, RT-PCR)

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Up to 80 favorable histology Wilms tumors that relapse (RFHWT), 50 anaplastic Wilms tumors (UHWT), 15 clear cell sarcomas of the kidney (CCSK), and 40 rhabdoid tumors (RT)

You may qualify if:

  • Diagnosis of high-risk Wilms tumor meeting ≥ 1 of the following criteria:
  • Relapsed disease
  • Anaplastic disease
  • Clear cell sarcomas of the kidney
  • Rhabdoid tumors
  • Registered on NWTS-4, NWTS-5 (now COG-Q9401), or participation in AREN03B2 protocols with clinical follow-up \> 3 years
  • Banked frozen tumor samples and paired normal DNA available with clinical data points, including the following:
  • Age, race, and gender
  • Stage and reason for stage
  • Tumor weight
  • Associated precursor lesions (rests)
  • Histologic subtype
  • Site and time of recurrence
  • Days of follow-up
  • Time and reasons for death (e.g., tumor, toxicity, infection, or other)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Archived tumor tissue samples

MeSH Terms

Conditions

Wilms Tumor

Interventions

DNA MethylationGene Expression ProfilingMicroarray AnalysisReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaGenetic TechniquesInvestigative TechniquesMicrochip Analytical ProceduresPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Elizabeth Perlman, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 6, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

US(1)