NCT01544569

Brief Summary

RATIONALE: Studying samples of tissue from patients with rhabdoid tumors in the laboratory may help doctor learn more about changes that occur in DNA and identify genes related to cancer. PURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid tumors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

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

First Submitted

Initial submission to the registry

February 29, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
4.2 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

4.2 years

First QC Date

February 29, 2012

Last Update Submit

May 17, 2016

Conditions

Kidney Cancer

Keywords

rhabdoid tumor of the kidney

Outcome Measures

Primary Outcomes (1)

  • Expression and function of transposons in rhabdoid tumors

Interventions

DNA analysisGENETIC
fluorescence in situ hybridizationGENETIC
gene expression analysisGENETIC
gene mappingGENETIC
microarray analysisGENETIC
polymerase chain reactionGENETIC
protein expression analysisGENETIC
laboratory biomarker analysisOTHER
medical chart reviewOTHER

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

rhabdoid tumors

DISEASE CHARACTERISTICS: * Freshly frozen rhabdoid tumors from either renal or extra-renal sites from children younger than 2 years of age * Clinical patient information (age, gender, comorbidities, tumor stage, size, pathology, therapy, outcome) available 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

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

In Situ Hybridization, FluorescenceGene Expression ProfilingChromosome MappingMicroarray AnalysisPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

In Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationMicrochip Analytical ProceduresNucleic Acid Amplification Techniques

Study Officials

  • Elizabeth A. Mullen, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 6, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05