Intracranial NeoplasmNCT04454268
Intracranial Hydatid Cyst
A study testing cyst extirpation in people with Intracranial Neoplasm, run by Sohag University.
Trial summary
Central nervous system (CNS) hydatid cysts is a rare presentation of hydatid cyst, although may be the cause of intracranial space-occupying lesions in 4% in endemic countries. It affects mostly children. The diagnosis of CNS hydatid is still problematic in spite of the advancements in imaging techniques (CT or MRI). Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Neoplasm
- What is being tested?
- cyst extirpation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 10 Jan 2018
- Phase
- Interventional
- 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 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- intracranial hydatid cyst
Who cannot join
- Arachnoid cysts
- conservative treatment
About this study
Official title: Intracranial Hydatid Cyst: Series of 8 Cases
Central nervous system (CNS) hydatid cysts is a rare presentation of hydatid cyst, although may be the cause of intracranial space-occupying lesions in 4% in endemic countries. It affects mostly children. The diagnosis of CNS hydatid is still problematic in spite of the advancements in imaging techniques (CT or MRI). Extirpation of the intact cyst is the treatment of choice, resulting in most cases to a complete recovery.
Read the detailed description
Hydatid disease is a parasitic induced disease caused by either Echinococcus granulosus or Echinococcus multilocularis during the larval stage of these tapeworms. Hydatid cysts are endemic in many countries, such as Latin America (Argentina, Brazil, Chile, Peru, and Uruguay); followed by Europe (France, Italy, and Greece), the Middle East (Turkey, Lebanon, Syria, and Jordan), Southeast Asia (China, Iran, and India) and Africa (Tunisia and less commonly, Egypt)
- Conditions
- Intracranial Neoplasm
- Being tested
- cyst extirpation
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyst extirpationProcedure or surgery
complete removal of the cyst without rupture
| Study group | Role | What they receive |
|---|---|---|
| hydatid cyst | Other | Not described Receives: Procedure: cyst extirpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who haven total removal of intracranial cyst
degree of consciousness incomplete extirpation without removal without neurological deficit 0 space
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jan 2010
- Primary completion1 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed salaheldin mohammed saro, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454268
- Sponsor's protocol ID
- Intracranial Hydatid Cyst
- Status last verified
- Jun 2020
- First submitted
- 27 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Hydatid Cyst: Series of 8 Cases
- ClinicalTrials.gov ID
- NCT04454268
- Acronym / sponsor ID
- Intracranial Hydatid Cyst
- Conditions
- Intracranial Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 1 Jul 2020 (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.
Central nervous system (CNS) hydatid cysts is a rare presentation of hydatid cyst, although may be the cause of intracranial space-occupying lesions in 4% in endemic countries. It affects mostly children. The diagnosis of CNS hydatid is still problematic in spite of the advancements in imaging techniques (CT or MRI). Extirpation of the intact cyst is the treatment of choice, resulting in most cases to a complete recovery.
Detailed description
Hydatid disease is a parasitic induced disease caused by either Echinococcus granulosus or Echinococcus multilocularis during the larval stage of these tapeworms. Hydatid cysts are endemic in many countries, such as Latin America (Argentina, Brazil, Chile, Peru, and Uruguay); followed by Europe (France, Italy, and Greece), the Middle East (Turkey, Lebanon, Syria, and Jordan), Southeast Asia (China, Iran, and India) and Africa (Tunisia and less commonly, Egypt)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hydatid cyst | Other | Procedure: cyst extirpation |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- intracranial hydatid cyst
Key exclusion criteria (2 listed)
- Arachnoid cysts
- conservative treatment
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 |
|---|---|---|
| cyst extirpationcomplete removal of the cyst without rupture | Procedure or surgery | hydatid cyst |
Primary outcome
number of patients who haven total removal of intracranial cyst
Time frame: 7 years
degree of consciousness incomplete extirpation without removal without neurological deficit 0 space
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 2 Jul 2020.
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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?
A study testing cyst extirpation in people with Intracranial Neoplasm, run by Sohag University.
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: finished, as of the sponsor's last update on 2 Jul 2020. 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?
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?
number of patients who haven total removal of intracranial cyst (time frame: 7 years). 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 2 Jul 2020.