Molecular Analysis of Retinoblastoma

Completed

• Conditions: Retinoblastoma
• Interventions: Other: Tissue samples taken from retinoblastoma; Other: 5 ml peripheral blood

• Registration Number: NCT00718783
• Lead Sponsor: St. Jude Children's Research Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-13
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retinoblastoma	5 ml peripheral blood	-
Retinoblastoma	Tissue samples taken from retinoblastoma	-

Primary Outcome Measures

Name	Time	Method
Identify genes exhibiting differential expression within intraocular disease tissue between patients having only intraocular involvement and those having extraocular involvement.	Indefinite

Trial Locations

Locations (2)

Hospital Calvo Mackenna; 🇨🇱 Santiago, Chile

Hospital Escuela Bloque Materno Infantil; 🇭🇳 Tegucigalpa, Honduras