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Molecular Analysis of Retinoblastoma

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ClinicalTrials.gov Identifier: NCT00718783
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : December 14, 2016
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Retinoblastoma Other: Tissue samples taken from retinoblastoma Other: 5 ml peripheral blood

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 Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Analysis of Retinoblastoma
Study Start Date : April 2007
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Identify genes exhibiting differential expression within intraocular disease tissue between patients having only intraocular involvement and those having extraocular involvement. [ Time Frame: Indefinite ]

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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718783


Locations
Chile
Hospital Calvo Mackenna
Santiago, Chile
Honduras
Hospital Escuela Bloque Materno Infantil
Tegucigalpa, Honduras
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Eye Institute (NEI)
Investigators
Principal Investigator: Rachel Brennan, MD St. Jude Children's Research Hospital

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00718783     History of Changes
Other Study ID Numbers: MARB
1R01EY018599 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016

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