NCT00010101

Brief Summary

RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer. PURPOSE: Genetic study to understand how genes may be involved in the development of brain tumors in young children.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2001

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

February 2, 2001

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

3.4 years

First QC Date

February 2, 2001

Last Update Submit

July 19, 2011

Conditions

Keywords

childhood choroid plexus tumoruntreated childhood supratentorial primitive neuroectodermal tumoruntreated childhood medulloblastomachildhood atypical teratoid/rhabdoid tumor

Outcome Measures

Primary Outcomes (1)

  • Deletions and mutations of the INI1 gene in infants with AT/RT, medulloblastoma, PNET, or choroid plexus carcinoma

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Tissue samples from infants (\< 3 years old) with histologically confirmed primary intracranial CNS medulloblastoma/PNET, atypical teratoid/rhabdoid tumor, or choroid plexus carcinoma and with no prior chemotherapy, radiotherapy, or treatment from any other investigational agent will be used for this research study. Patients who meet the eligibility criteria, are treated at a PBTC institution that has IRB approval of this study, and consent to the usage of stored tumor specimens for the study objectives constitute the study population.

DISEASE CHARACTERISTICS: * Histologically confirmed primary intracranial central nervous system tumor * Medulloblastoma * Primitive neuroectodermal tumor * Atypical teratoid/rhabdoid tumor * Choroid plexus carcinoma * Potential enrollment on PBTC-001 therapeutic protocol PATIENT CHARACTERISTICS: Age: * Under 3 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior steroids allowed Radiotherapy: * No prior radiotherapy Surgery: * Not specified Other: * No concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (4)

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Texas Children's Cancer Center

Houston, Texas, 77030-2399, United States

Location

Related Publications (1)

  • Pomeroy SL, Tamayo P, Gaasenbeek M, Sturla LM, Angelo M, McLaughlin ME, Kim JY, Goumnerova LC, Black PM, Lau C, Allen JC, Zagzag D, Olson JM, Curran T, Wetmore C, Biegel JA, Poggio T, Mukherjee S, Rifkin R, Califano A, Stolovitzky G, Louis DN, Mesirov JP, Lander ES, Golub TR. Prediction of central nervous system embryonal tumour outcome based on gene expression. Nature. 2002 Jan 24;415(6870):436-42. doi: 10.1038/415436a.

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples

MeSH Terms

Conditions

Central Nervous System NeoplasmsChoroid Plexus NeoplasmsRhabdoid Tumor

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesCerebral Ventricle NeoplasmsBrain NeoplasmsBrain DiseasesCentral Nervous System DiseasesNeoplasms, Complex and MixedNeoplasms by Histologic Type

Study Officials

  • Jaclyn A. Biegel, PhD

    Children's Hospital of Philadelphia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations