Cancer Biology of Retinoblastoma

NCT01642823 | Terminated DMC

• 1 other identifier: PEDSEYE0002
• Study Type: observational
• Target: 8
• Locations: 2 countries
• Sites: 2

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.

Conditions

Retinoblastoma

Keywords

retinoblastoma

Outcome Measures

Primary Outcomes (1)

• Change in efficiency of reprogramming in cells with "naturally occurring" retinoblastoma mutations

  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.

  After appropriate time, e.g., 7, 10, 14 days after reprogramming

Study Arms (1)

retinablastoma tumor tissue

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• Diagnosis other than Retinoblastoma
• No surgical sampling of tumor is planned as part of standard care
• Parental preference to not participate.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford University Cancer Institute

Stanford, California, 94305, United States

Location

Unidad Nacional de Oncologia Pediatrica

Guatemala City, Guatemala

Location

Biospecimen

Retention: SAMPLES WITH DNA

retinoblastoma tumor tissue sample

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

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, Hereditary; Eye Diseases; Retinal Diseases

Study Officials

• Julien Sage

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

US (1); GU (1)