- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01642823
Cancer Biology of Retinoblastoma
March 2, 2017 updated by: Stanford University
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
8
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Guatemala, Guatemala
- Unidad Nacional De Oncologia Pediatrica
-
-
-
-
California
-
Stanford, California, United States, 94305
- Stanford University Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
retinablastoma tumor tissue
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
After appropriate time, e.g., 7, 10, 14 days after reprogramming
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julien Sage, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 11, 2012
First Submitted That Met QC Criteria
July 12, 2012
First Posted (Estimate)
July 17, 2012
Study Record Updates
Last Update Posted (Actual)
March 6, 2017
Last Update Submitted That Met QC Criteria
March 2, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Retinal Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Eye Diseases, Hereditary
- Eye Neoplasms
- Retinal Neoplasms
- Retinoblastoma
Other Study ID Numbers
- PEDSEYE0002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Retinoblastoma
-
Children's Oncology GroupRecruitingBilateral Retinoblastoma | Childhood Intraocular Retinoblastoma | Unilateral Retinoblastoma | Group D Retinoblastoma | Stage I RetinoblastomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedIntraocular Retinoblastoma | Recurrent Retinoblastoma | Extraocular RetinoblastomaUnited States, Canada, Puerto Rico
-
Children's Hospital Los AngelesRecruitingRetinoblastoma | Retinoblastoma Bilateral | Retinoblastoma UnilateralUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)RecruitingCancer Survivor | Retinoblastoma | Unilateral Retinoblastoma | Intraocular Retinoblastoma | Biological SiblingUnited States, Canada
-
Amsterdam UMC, location VUmcRecruitingRetinoblastoma | Trilateral RetinoblastomaNetherlands
-
Hospital JP GarrahanHospital San Juan de Dios, SantiagoActive, not recruitingUnilateral RetinoblastomaArgentina
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUnilateral RetinoblastomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingExtraocular RetinoblastomaUnited States, Canada, Australia, Brazil, Argentina, Egypt
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedIntraocular RetinoblastomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedIntraocular RetinoblastomaUnited States