Feasibility of Generating Pluripotent Stem Cells From Patients With Familial Retinoblastoma
NCT ID: NCT02193724
Last Updated: 2020-10-23
Study Results
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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COMPLETED
15 participants
OBSERVATIONAL
2014-11-04
2019-08-23
Brief Summary
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OBJECTIVES:
* To establish the feasibility of producing induced pluripotent stem cells (iPSCs) from retinoblastoma patients with germline RB1 mutations (RB1-deficient iPSCs).
* To validate human RB1-deficient iPSCs by confirming karyotype, pluripotency and RB1 mutation.
* To differentiate the RB1-deficient iPSCs into retina as a model of the initiation of retinoblastoma in the developing retina.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Retinoblastoma
Participants identified with heritable retinoblastoma will undergo a skin biopsy or blood draw to collect cells for processing and analysis.
Skin Biopsy
A very small skin sample will be taken from the participant's arm. This will only be performed while the patient is under sedation for clinical purposes (e.g. exam under anesthesia, MRI, or other procedure requiring sedation).
Blood Draw
About 1 teaspoon of blood will be drawn from the participant's arm or from a central line catheter if present. Blood collection will be done at the same time the participant has blood drawn for routine clinical care.
Interventions
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Skin Biopsy
A very small skin sample will be taken from the participant's arm. This will only be performed while the patient is under sedation for clinical purposes (e.g. exam under anesthesia, MRI, or other procedure requiring sedation).
Blood Draw
About 1 teaspoon of blood will be drawn from the participant's arm or from a central line catheter if present. Blood collection will be done at the same time the participant has blood drawn for routine clinical care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Family history with RB1 mutation identified
* Diagnosis of bilateral retinoblastoma
* Diagnosis of unilateral retinoblastoma with RB1 mutation or MYCN amplification identified
* Participant or legal guardian/representative is able and willing to provide written informed consent.
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Rachel C. Brennan, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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RETCELL
Identifier Type: -
Identifier Source: org_study_id
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