NCT00010114

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 learn more about genes involved in the development of central nervous system tumors in young children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2001

Geographic Reach
1 country

9 active sites

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

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
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

2 years

First QC Date

February 2, 2001

Last Update Submit

July 19, 2011

Conditions

Keywords

childhood central nervous system germ cell tumorchildhood choroid plexus tumoruntreated childhood supratentorial primitive neuroectodermal tumoruntreated childhood medulloblastomanewly diagnosed childhood ependymoma

Outcome Measures

Primary Outcomes (1)

  • Genes that are expressed in metastatic vs. non-metastatic tumors

    Prior to therapy

Secondary Outcomes (1)

  • Protein expression of genes found to be expressed

    Prior to therapy

Study Arms (1)

Newly diagnosed embryonal tumors

The participants in this study are infants (\< 3 years of age) with newly diagnosed medulloblastoma, primitive neuroectodermal tumor, or other embryonal tumor, atypical teratoid/rhabdoid tumor, intracranial germ cell tumor, or choroid plexus carcinoma who have received no prior therapy with the exception of steroids and have consented to allow research studies on banked tissue specimens

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The participants in this study are infants (\< 3 years of age) with newly diagnosed medulloblastoma, primitive neuroectodermal tumor, or other embryonal tumor, atypical teratoid/rhabdoid tumor, intracranial germ cell tumor, or choroid plexus carcinoma who have received no prior therapy with the exception of steroids and have consented to allow research studies on banked tissue specimens

DISEASE CHARACTERISTICS: * Histologically confirmed, newly diagnosed, primary intracranial embryonal central nervous system tumor * Medulloblastoma * Primitive neuroectodermal tumor * Medulloepithelioma * Ependymoblastoma * Neuroblastoma * Pineoblastoma * Atypical teratoid/rhabdoid tumor * Intracranial germ cell tumor * Choroid plexus carcinoma * M positive ependymoma * 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 (9)

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Children's National Medical Center

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

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Choroid Plexus Neoplasms

Condition Hierarchy (Ancestors)

Cerebral Ventricle NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Tobey MacDonald, MD

    Children's National Research Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

February 2, 2001

First Posted

June 6, 2003

Study Start

March 1, 2001

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations