Pineal Gland DisorderNCT03183427
Corpus Callosum Size in Patients With Pineal Cyst
An observational study of Pineal Gland Disorder and Corpus Callosum Atrophy, run by Military University Hospital, Prague.
Trial summary
This study aims to determine size of corpus callosum on midsagittal MR scan in patients with a pineal cyst and to compare it with the control group without a pineal cyst. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pineal Gland Disorder, Corpus Callosum Atrophy, Cerebral Palsy
- What is being tested?
- MR of the brain
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Sep 2018
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * study group: consecutive patients with pineal cyst that were examined in our institution between 2000-2017 * control group: matched healthy subjects without pineal cyst
Who may be able to join
- 3T MR examination of the brain including T2 sagittal scans
Who cannot join
- other intracranial pathology discovered on the MR
- other known neurological disease (e.g. multiple sclerosis, stroke, tumor, etc.)
About this study
This study aims to determine size of corpus callosum on midsagittal MR scan in patients with a pineal cyst and to compare it with the control group without a pineal cyst.
Read the detailed description
A pineal cyst (PC) is a benign affection of the pineal gland, its prevalence in population reaches 1-2 %. Etiopathogenesis of PC is unknown, several hypotheses have been proposed. One of the hypothesis consider perinatal hypoxia as a causative factor for a development of PC in later life. Ozmen et al. showed significantly higher prevalence of PC in patients with cerebral palsy (p<0.001). Bregant et al. studied presence of PC in patients that suffered from a mild to moderate perinatal hypoxia. Prevalence of PC reached 36 % in these patients and presence of PC was associated with a atrophy of the corpus callosum (p<0.005). The atrophy of the corpus callosum is considered to be a sign of a periventricular leukomalacia, i.e. an ischemic insult in a perinatal period.
In the present study, we are going to compare an area of corpus callosum on a midsagittal magnetic resonance T2-weighted scan in the group of patients with PC and in the control group without PC. The goal of the study is to determine if there is a relationship between atrophy of the corpus callosum and PC. Such finding would support abovementioned theory of etiopathogenesis of PC.
- Being tested
- MR of the brain
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR of the brainDiagnostic test
MR of the brain without gadolinium, incl. T2-weighted image
| Study group | Role | What they receive |
|---|---|---|
| Group of patients with pineal cyst | Group of patients with pineal cyst Receives: Diagnostic Test: MR of the brain | |
| Control group | Group of subjects without pineal cyst Receives: Diagnostic Test: MR of the brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
size of corpus callosum
size of corpus callosum in mm2 measured on the midsagittal T2-weighted MR scan
Measured: time of the MR examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study startSep 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pineal Gland DisorderStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Majovsky, MD, Military University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183427
- Sponsor's protocol ID
- 108/11-28/2017
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corpus Callosum Size in Patients With Pineal Cyst
- ClinicalTrials.gov ID
- NCT03183427
- Acronym / sponsor ID
- 108/11-28/2017
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Military University Hospital, PragueUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 12 Jun 2017 (actual)
- 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.
This study aims to determine size of corpus callosum on midsagittal MR scan in patients with a pineal cyst and to compare it with the control group without a pineal cyst.
Detailed description
A pineal cyst (PC) is a benign affection of the pineal gland, its prevalence in population reaches 1-2 %. Etiopathogenesis of PC is unknown, several hypotheses have been proposed. One of the hypothesis consider perinatal hypoxia as a causative factor for a development of PC in later life. Ozmen et al. showed significantly higher prevalence of PC in patients with cerebral palsy (p<0.001). Bregant et al. studied presence of PC in patients that suffered from a mild to moderate perinatal hypoxia. Prevalence of PC reached 36 % in these patients and presence of PC was associated with a atrophy of the corpus callosum (p<0.005). The atrophy of the corpus callosum is considered to be a sign of a periventricular leukomalacia, i.e. an ischemic insult in a perinatal period.
In the present study, we are going to compare an area of corpus callosum on a midsagittal magnetic resonance T2-weighted scan in the group of patients with PC and in the control group without PC. The goal of the study is to determine if there is a relationship between atrophy of the corpus callosum and PC. Such finding would support abovementioned theory of etiopathogenesis of PC.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of patients with pineal cyst | – | Diagnostic Test: MR of the brainGroup of patients with pineal cyst |
| Control group | – | Diagnostic Test: MR of the brainGroup of subjects without pineal cyst |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * study group: consecutive patients with pineal cyst that were examined in our institution between 2000-2017 * control group: matched healthy subjects without pineal cyst
Key inclusion criteria (1 listed)
- 3T MR examination of the brain including T2 sagittal scans
Key exclusion criteria (2 listed)
- other intracranial pathology discovered on the MR
- other known neurological disease (e.g. multiple sclerosis, stroke, tumor, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR of the brainMR of the brain without gadolinium, incl. T2-weighted image | Diagnostic test | Control group, Group of patients with pineal cyst |
Primary outcome
size of corpus callosum
Time frame: time of the MR examination
size of corpus callosum in mm2 measured on the midsagittal T2-weighted MR scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pineal Gland Disorder and Corpus Callosum Atrophy, run by Military University Hospital, Prague.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
size of corpus callosum (time frame: time of the MR examination). 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 14 Jun 2017.