Molecular Analysis of Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

Molecular Analysis of Retinoblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718783
• Other study ID #: MARB
• Secondary ID: 1R01EY018599
• Status: Completed
• Phase: N/A
• First received: July 17, 2008
• Last updated: December 13, 2016
• Start date: April 2007
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Other:
• Tissue samples taken from retinoblastoma
Tissue banking
• 5 ml peripheral blood
White blood cells will be isolated from the blood sample as a source of genomic DNA.

Locations

Country	Name	City	State
Chile	Hospital Calvo Mackenna	Santiago
Honduras	Hospital Escuela Bloque Materno Infantil	Tegucigalpa

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Eye Institute (NEI)

Countries where clinical trial is conducted

Chile,  Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify genes exhibiting differential expression within intraocular disease tissue between patients having only intraocular involvement and those having extraocular involvement.		Indefinite	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital