RetinoblastomaNCT01884194
Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging
An observational study of Retinoblastoma and Pineoblastoma, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients Read more about this study
- Who is it for?
- Ages 1 day to 50 years
- Conditions the study is for
- Retinoblastoma, Pineoblastoma
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Feb 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 1 day to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients with retinoblastoma
Who may be able to join
- diagnosis of retinoblastoma
- brain MRI available
Who cannot join
- insufficient quality of brain MRI
Trial locations and contacts
1 site in 1 country.
About this study
MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients
- Conditions
- Retinoblastoma, Pineoblastoma
- Keywords
- retinoblastoma, pineoblastoma
- Medical subject headings
- Retinoblastoma, Pinealoma
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 |
|---|---|---|
| Retinoblastoma patients | patients with diagnosed retinoblastoma | |
| non-retinoblastoma patients | aged matched control cohort without the diagnosis of ocular or brain tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignancy criteria of pineal gland
size of pineal gland solid or cystic component (all at baseline)
Measured: clinical follow-up 1-year after baseline imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thi Thai Hien Pham, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884194
- Sponsor's protocol ID
- RTB_0305_outcome
- Status last verified
- Dec 2015
- First submitted
- 24 May 2013
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pham TT, Siebert E, Asbach P, Willerding G, Erb-Eigner K. Magnetic resonance imaging based morphologic evaluation of the pineal gland for suspected pineoblastoma in retinoblastoma patients and age-matched controls. J Neurol Sci. 2015 Dec 15;359(1-2):185-92. doi: 10.1016/j.jns.2015.10.046. Epub 2015 Oct 28.
PubMed 26671110
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01884194
- Acronym / sponsor ID
- RTB_0305_outcome
- Conditions
- Retinoblastoma, Pineoblastoma
- Keywords
- retinoblastoma, pineoblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Jun 2013 (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.
MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retinoblastoma patients | – | –patients with diagnosed retinoblastoma |
| non-retinoblastoma patients | – | –aged matched control cohort without the diagnosis of ocular or brain tumor |
Who may qualify
- Ages
- 1 day to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients with retinoblastoma
Key inclusion criteria (2 listed)
- diagnosis of retinoblastoma
- brain MRI available
Key exclusion criteria (1 listed)
- insufficient quality of brain MRI
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
Malignancy criteria of pineal gland
Time frame: clinical follow-up 1-year after baseline imaging
size of pineal gland solid or cystic component (all at baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
- Derived from this study: PubMed 26671110Pham TT, Siebert E, Asbach P, Willerding G, Erb-Eigner K. Magnetic resonance imaging based morphologic evaluation of the pineal gland for suspected pineoblastoma in retinoblastoma patients and age-matched controls. J Neurol Sci. 2015 Dec 15;359(1-2):185-92. doi: 10.1016/j.jns.2015.10.046. Epub 2015 Oct 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinoblastoma and Pineoblastoma, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Malignancy criteria of pineal gland (time frame: clinical follow-up 1-year after baseline imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01884194, which also lists 1 linked publication.
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 29 Dec 2015.