Molecular Analysis of Retinoblastoma - Full Text View

Sponsored by:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00718783

Purpose

Retinoblastoma is a childhood tumor of the retina that affects approximately 1 in 18,000 children Retinoblastoma is more prevalent in Central America, where most patients present with advanced intraocular and extraocular disease. Therefore, we have formed collaboration with Central American investigators to provide us with frozen retinoblastoma tumors from patients undergoing routine enucleation. The objective of this protocol is to begin to identify the mutations and gene expression changes that occur in retinoblastoma cells following RB1 gene inactivation in order to more effectively target chemotherapy for treating bilateral retinoblastoma.

Condition	Intervention
Retinoblastoma	Procedure: Enucleation of the eye

Genetics Home Reference related topics: retinoblastoma

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Molecular Analysis of Retinoblastoma

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

Identify genes exhibiting differential expression within intraocular disease tissue between patients having only intraocular involvement and those having extraocular involvement. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2007
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Procedure: Enucleation of the eye Removal of the eye

Detailed Description:

This is a biology protocol with no treatment regimen associated. Following routine enucleation of the retinoblastoma affected eye, a portion of the tumor will be removed and flash frozen and sent to St. Jude for RNA and DNA analysis. Some tissue will undergo histopathological analysis and tissue microarrays will be isolated. The remaining tumor will be returned to the participating hospital in Central America for permanent storage.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have clinical diagnosis of retinoblastoma (to be confirmed histologically after enucleation)
Legal guardians must willing to sign an informed consent indicating that they are aware of this study and its possible benefits. Legal guardians will be given a copy of the consent form.
Patient is being seen at this AHOPCA institution:

Hospital Escuela Bloque Materno Infantil, Tegucigalpa, Honduras

Patient must be willing and able to provide 5ml of blood during surgery.

Exclusion Criteria:

Ophthalmologist or oncologist is concerned that sampling will interfere with staging.
Diagnosis other than retinoblastoma.
Affiliated hospital is unable to provide pathologic evidence of retinoblastoma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718783

Contacts

Contact: Michael A Dyer, PhD

1-866-278-5833

info@stjude.org

Locations

United States, Tennessee
St. Jude Children's Research Hostpital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: Michael A Dyer, PhD 866-278-5833 info@stjude.org
Principal Investigator: Michael A Dyer, PhD
Honduras
Hospital Escuela Bloque Materno Infantil	Recruiting
Tegucigalpa, Honduras
Contact: Ligia Fu, MD 222-2322 ext 316 ligiafucarrasco@yahoo.com
Principal Investigator: Ligia Fu, MD

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:

Michael A Dyer, PhD

St. Jude Children's Research Hospital

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	St. Jude Children's Research Hospital ( Michael A. Dyer, PhD )
Study ID Numbers:	MARB
Study First Received:	July 17, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00718783
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Retinal Neoplasms
Neuroectodermal Tumors
Eye Neoplasms
Eye Diseases
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Retinoblastoma
Retinal Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 13, 2009