RetinoblastomaNCT01642823
Cancer Biology of Retinoblastoma
An observational study of Retinoblastoma, run by Stanford University at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Retinoblastoma
- How many people
- 8 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Retinoblastoma patients undergoing surgical removal of part or all of their tumor, with or without the remainder of the eye
Who may be able to join
- 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
Who cannot join
- Diagnosis other than Retinoblastoma
- No surgical sampling of tumor is planned as part of standard care
- Parental preference to not participate.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Stanford University Cancer Institute
Stanford, California, 94305
About this study
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
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| retinablastoma tumor tissue | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After appropriate time, e.g., 7, 10, 14 days after reprogramming
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Sage, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642823
- Sponsor's protocol ID
- PEDSEYE0002
- Status last verified
- Mar 2017
- First submitted
- 11 Jul 2012
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Biology of Retinoblastoma
- ClinicalTrials.gov ID
- NCT01642823
- Acronym / sponsor ID
- PEDSEYE0002
- Conditions
- Retinoblastoma
- Keywords
- retinoblastoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Logistics
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| retinablastoma tumor tissue | – | – |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Retinoblastoma patients undergoing surgical removal of part or all of their tumor, with or without the remainder of the eye
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis other than Retinoblastoma
- No surgical sampling of tumor is planned as part of standard care
- Parental preference to not participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Logistics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Sage principal investigator
Stanford University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinoblastoma, run by Stanford University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Logistics). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.