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Cancer Biology of Retinoblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01642823
First received: July 11, 2012
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

Many children with the childhood cancer, Retinoblastoma, have surgery to remove the tumor and sometimes the entire eye. The purpose of this study is to collect the extra tissue from patients who undergo tumor removal for laboratory experiments that will help us understand not only what occurs in retinoblastoma cells but also how cells normally function. Some of these studies will include an evaluation of how cells control the way that genes are expressed, how cells "know" to become retinal cells, how cells remain retinal cells, how cells lose their identity as retinal cells, what changes make retinoblastoma cells different from normal retinal cells, and what changes make some retinoblastomas worse than others.


Condition
Retinoblastoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Cancer Biology of Retinoblastoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change in efficiency of reprogramming in cells with "naturally occurring" retinoblastoma mutations [ Time Frame: After appropriate time, e.g., 7, 10, 14 days after reprogramming ] [ Designated as safety issue: No ]
    Comparison of number of reprogramming events (defined by colony formation assay and normalized for number of cell plated) as well as the time to reprogramming.


Biospecimen Retention:   Samples With DNA

retinoblastoma tumor tissue sample


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
retinablastoma tumor tissue

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Retinoblastoma patients undergoing surgical removal of part or all of their tumor, with or without the remainder of the eye

Criteria

Inclusion Criteria:

  • Patient must have retinoblastoma
  • Patient must be receiving biopsy, partial surgical excision of the tumor, complete excision of the tumor, or enucleation of the eye as part of their standard care.
  • Parental consent

Exclusion Criteria:

  • Diagnosis other than Retinoblastoma
  • No surgical sampling of tumor is planned as part of standard care
  • Parental preference to not participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642823

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Phillip Garfin    650-497-8953    pgarfin@stanford.edu   
Sub-Investigator: Phillip Garfin         
Sub-Investigator: Douglas Fredrick         
Sub-Investigator: Michael Kareta         
Principal Investigator: Sandra Luna-Fineman         
Principal Investigator: Julien Sage         
Guatemala
Unidad Nacional de Oncologia Pediatrica Recruiting
Guatemala, Guatemala
Contact: Claudia Garrido    50224454204      
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Phillip Garfin Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01642823     History of Changes
Other Study ID Numbers: PEDSEYE0002
Study First Received: July 11, 2012
Last Updated: October 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
retinoblastoma

Additional relevant MeSH terms:
Eye Neoplasms
Retinoblastoma
Eye Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Retinal Diseases
Retinal Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014