Cancer Biology of Retinoblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01642823
Recruitment Status : Terminated (Logistics)
First Posted : July 17, 2012
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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 or disease

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Cancer Biology of Retinoblastoma
Study Start Date : July 2012
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

retinablastoma tumor tissue

Primary Outcome Measures :
  1. 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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

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.

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 identifier (NCT number): NCT01642823

United States, California
Stanford University Cancer Institute
Stanford, California, United States, 94305
Unidad Nacional de Oncologia Pediatrica
Guatemala, Guatemala
Sponsors and Collaborators
Stanford University
Principal Investigator: Julien Sage Stanford University

Responsible Party: Stanford University Identifier: NCT01642823     History of Changes
Other Study ID Numbers: PEDSEYE0002
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by Stanford University:

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