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Molecular Analysis of Retinoblastoma

NCT ID: NCT00718783

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Retinoblastoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Retinoblastoma

Tissue samples taken from retinoblastoma

Intervention Type OTHER

Tissue banking

5 ml peripheral blood

Intervention Type OTHER

White blood cells will be isolated from the blood sample as a source of genomic DNA.

Interventions

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Tissue samples taken from retinoblastoma

Tissue banking

Intervention Type OTHER

5 ml peripheral blood

White blood cells will be isolated from the blood sample as a source of genomic DNA.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Brennan, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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Hospital Calvo Mackenna

Santiago, Santiago Metropolitan, Chile

Site Status

Hospital Escuela Bloque Materno Infantil

Tegucigalpa, , Honduras

Site Status

Countries

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Argentina United States Chile Honduras

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

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1R01EY018599

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MARB

Identifier Type: -

Identifier Source: org_study_id