NCT01553175

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial studies gene expression in samples from patients with rhabdoid tumors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 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

March 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

4.3 years

First QC Date

March 10, 2012

Last Update Submit

July 13, 2016

Conditions

Brain and Central Nervous System TumorsKidney Cancer

Keywords

childhood atypical teratoid/rhabdoid tumorrhabdoid tumor of the kidney

Outcome Measures

Primary Outcomes (2)

  • Absence or presence BRG1 and BRM expression in rhabdoid tumors

  • Mechanism of suppression of BRG1 and BRM genes

Interventions

DNA analysisGENETIC
gene expression analysisGENETIC
mutation analysisGENETIC
protein expression analysisGENETIC
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with rhabdoid tumors

DISEASE CHARACTERISTICS: * Tumor samples from patients diagnosed with rhabdoid tumors * Matched frozen tumor tissue from BRG1-negative tumors (preferred) or matched genomic DNA from tumors, 100 ng per tumor from BRG1-negative tumors * Any source of DNA from BRG1-negative tumors (tumors, blood, etc.) * Matched frozen tumor tissue from BRM-negative tumors to confirm that BRM is not mutated or altered but rather epigenetically suppressed when lost in rhabdoid tumors 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

Central Nervous System NeoplasmsKidney NeoplasmsRhabdoid Tumor

Interventions

Gene Expression ProfilingImmunohistochemistry

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms, Complex and MixedNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • David Reisman, MD, PhD

    University of Florida

    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

March 10, 2012

First Posted

March 14, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07