Molecular Analysis of Retinoblastoma
This study is currently recruiting participants.
Verified April 2013 by St. Jude Children's Research Hospital
Sponsor:
St. Jude Children's Research Hospital
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00718783
First received: July 17, 2008
Last updated: April 23, 2013
Last verified: April 2013
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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 |
Other: Tissue samples taken from retinoblastoma Other: 5 ml peripheral blood |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Molecular Analysis of Retinoblastoma |
Resource links provided by NLM:
Genetics Home Reference related topics:
retinoblastoma
MedlinePlus related topics:
Cancer
U.S. FDA Resources
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: Indefinite ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
- Each tumor sample will be immediately transferred to a sterile cryovial and flash frozen in liquid nitrogen.
- White blood cells will be isolated from the blood sample as a source of genomic DNA.
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Retinoblastoma |
Other: Tissue samples taken from retinoblastoma
Tissue banking
Other: 5 ml peripheral blood
White blood cells will be isolated from the blood sample as a source of genomic DNA.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with retinoblastoma
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:
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: Rachel Brennan, MD | 1-866-278-5833 | info@stjude.org |
Locations
| Argentina | |
| Hospital JP Garrahan | Not yet recruiting |
| Buenos Aires, Combate de los Pozos, Argentina, C1245AAL | |
| Contact: Guillermo Chantada, MD | |
| Principal Investigator: Guillermo Chantada, MD | |
| Chile | |
| Hospital Calvo Mackenna | Recruiting |
| Santiago, Chile | |
| Contact: Milena Villarroel, MD | |
| Principal Investigator: Milena Villarroel, MD | |
| 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: | Rachel Brennan, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00718783 History of Changes |
| Other Study ID Numbers: | MARB, 1R01EY018599 |
| Study First Received: | July 17, 2008 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Retinoblastoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Retinal Neoplasms Eye Neoplasms Neoplasms by Site Eye Diseases Retinal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013