Brain TumorNCT05781984
Role of Surgery in Management of Pineal Region Tumors in Children
An observational study of Brain Tumor, run by Assiut University.
Trial summary
The aim of this observational study is to learn about the role of surgery with its different approaches and modalities in the management of pineal region tumors in pediatric population.the main question it aims to answer is : How can surgery affect the outcome in children with pineal region tumors ? Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Microsugical Excsosion
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Jan 2024
- 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 2 months to 18 years
- All sexes
- Child, Adult
Study population: Pediatric population with age of 18 years old or younger diagnosed with pineal region tumor and fit for surgical intervention
Who may be able to join
- All patients with pineal region tumors with age less than or equal to 18 years old and fit for surgical intervention
Who cannot join
- patients with pineal region tumors older than 18 years old
- and pediatric patients younger than 18 years ild and unfit for surgical intervention
Trial locations and contacts
No sites are listed yet.
Roshdy Abdelaziz Elkhayat, MD, Professor of Neurosurgery contact
About this study
The aim of this observational study is to learn about the role of surgery with its different approaches and modalities in the management of pineal region tumors in pediatric population.the main question it aims to answer is : How can surgery affect the outcome in children with pineal region tumors ?
- Conditions
- Brain Tumor
- Being tested
- Microsugical Excsosion
- Keywords
- pineal region
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsugical ExcsosionProcedure or surgery
Also called Endoscopic Biopsy
Microsurgical excision of pineal region tumor or endoscopic biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
role of surgery and its effect in improving quality of life in children with pineal region tumors
evaluation of effect of surgical management with its different approaches in improvement of quality of life and performance status using Karnofsky Performance score (KPS) and radiological imaging till referral to adjuvant therapy
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study startApr 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Ibrahim Alghriany, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781984
- Sponsor's protocol ID
- Pineal Region Tumors
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Choudhry O, Gupta G, Prestigiacomo CJ. On the surgery of the seat of the soul: the pineal gland and the history of its surgical approaches. Neurosurg Clin N Am. 2011 Jul;22(3):321-33, vii. doi: 10.1016/j.nec.2011.04.001.
PubMed 21801980Li Y, Zhao G, Wang H, Zhu W, Qu L, Li Y, Yu J. Use of 3D-computed tomography angiography for planning the surgical removal of pineal region meningiomas using Poppen's approach: a report of ten cases and a literature review. World J Surg Oncol. 2011 Jun 15;9:64. doi: 10.1186/1477-7819-9-64.
PubMed 21676231Blakeley JO, Grossman SA. Management of pineal region tumors. Curr Treat Options Oncol. 2006 Nov;7(6):505-16. doi: 10.1007/s11864-006-0025-6.
PubMed 17032562Mottolese C, Szathmari A, Beuriat PA. Incidence of pineal tumours. A review of the literature. Neurochirurgie. 2015 Apr-Jun;61(2-3):65-9. doi: 10.1016/j.neuchi.2014.01.005. Epub 2014 Aug 10.
PubMed 25113513Mori Y, Kobayashi T, Hasegawa T, Yoshida K, Kida Y. Stereotactic radiosurgery for pineal and related tumors. Prog Neurol Surg. 2009;23:106-118. doi: 10.1159/000210057. Epub 2009 Mar 23.
PubMed 19329865Wang P, Mao Q, Wang W, Zhou LX, Liu YH. Gamma knife surgery for pineal region tumors: an alternative strategy for negative pathology. Arq Neuropsiquiatr. 2014 Feb;72(2):129-35. doi: 10.1590/0004-282X20130217.
PubMed 24604367Behari S, Garg P, Jaiswal S, Nair A, Naval R, Jaiswal AK. Major surgical approaches to the posterior third ventricular region: A pictorial review. J Pediatr Neurosci. 2010 Jul;5(2):97-101. doi: 10.4103/1817-1745.76093. No abstract available.
PubMed 21559151Poppen JL. The right occipital approach to a pinealoma. J Neurosurg. 1966 Dec;25(6):706-10. doi: 10.3171/jns.1966.25.6.0706. No abstract available.
PubMed 5925731Dandy WE. EXTIRPATION OF THE PINEAL BODY. J Exp Med. 1915 Aug 1;22(2):237-46. doi: 10.1084/jem.22.2.237.
PubMed 19867913Morgenstern PF, Souweidane MM. Pineal region tumors: simultaneous endoscopic third ventriculostomy and tumor biopsy. World Neurosurg. 2013 Feb;79(2 Suppl):S18.e9-13. doi: 10.1016/j.wneu.2012.02.020. Epub 2012 Feb 10.
PubMed 22381843Masina R, Ansaripour A, Benes V, Berhouma M, Choque-Velasquez J, Eide PK, Fedorko S, Fleck S, Hernesniemi J, Koziarski A, Majovsky M, Podgorski A, Schroeder H, Teo C, Unterberg AW, Yeung JT, Kolias A, Santarius T. Surgical treatment of symptomatic pineal cysts without hydrocephalus-meta-analysis of the published literature. Acta Neurochir (Wien). 2022 Jan;164(1):61-77. doi: 10.1007/s00701-021-05054-0. Epub 2021 Dec 2.
PubMed 34854993
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Surgery in Management of Pineal Region Tumors in Children
- ClinicalTrials.gov ID
- NCT05781984
- Acronym / sponsor ID
- Pineal Region Tumors
- Conditions
- Brain Tumor
- Keywords
- pineal region
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 23 Mar 2023 (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.
The aim of this observational study is to learn about the role of surgery with its different approaches and modalities in the management of pineal region tumors in pediatric population.the main question it aims to answer is : How can surgery affect the outcome in children with pineal region tumors ?
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric population with age of 18 years old or younger diagnosed with pineal region tumor and fit for surgical intervention
Key inclusion criteria (1 listed)
- All patients with pineal region tumors with age less than or equal to 18 years old and fit for surgical intervention
Key exclusion criteria (2 listed)
- patients with pineal region tumors older than 18 years old
- and pediatric patients younger than 18 years ild and unfit for surgical intervention
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 |
|---|---|---|
| Microsugical ExcsosionAlso: Endoscopic BiopsyMicrosurgical excision of pineal region tumor or endoscopic biopsy | Procedure or surgery | – |
Primary outcome
role of surgery and its effect in improving quality of life in children with pineal region tumors
Time frame: three years
evaluation of effect of surgical management with its different approaches in improvement of quality of life and performance status using Karnofsky Performance score (KPS) and radiological imaging till referral to adjuvant therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 21801980Choudhry O, Gupta G, Prestigiacomo CJ. On the surgery of the seat of the soul: the pineal gland and the history of its surgical approaches. Neurosurg Clin N Am. 2011 Jul;22(3):321-33, vii. doi: 10.1016/j.nec.2011.04.001.
- Background: PubMed 21676231Li Y, Zhao G, Wang H, Zhu W, Qu L, Li Y, Yu J. Use of 3D-computed tomography angiography for planning the surgical removal of pineal region meningiomas using Poppen's approach: a report of ten cases and a literature review. World J Surg Oncol. 2011 Jun 15;9:64. doi: 10.1186/1477-7819-9-64.
- Background: PubMed 17032562Blakeley JO, Grossman SA. Management of pineal region tumors. Curr Treat Options Oncol. 2006 Nov;7(6):505-16. doi: 10.1007/s11864-006-0025-6.
- Background: PubMed 25113513Mottolese C, Szathmari A, Beuriat PA. Incidence of pineal tumours. A review of the literature. Neurochirurgie. 2015 Apr-Jun;61(2-3):65-9. doi: 10.1016/j.neuchi.2014.01.005. Epub 2014 Aug 10.
- Background: PubMed 19329865Mori Y, Kobayashi T, Hasegawa T, Yoshida K, Kida Y. Stereotactic radiosurgery for pineal and related tumors. Prog Neurol Surg. 2009;23:106-118. doi: 10.1159/000210057. Epub 2009 Mar 23.
- Background: PubMed 24604367Wang P, Mao Q, Wang W, Zhou LX, Liu YH. Gamma knife surgery for pineal region tumors: an alternative strategy for negative pathology. Arq Neuropsiquiatr. 2014 Feb;72(2):129-35. doi: 10.1590/0004-282X20130217.
- Background: PubMed 21559151Behari S, Garg P, Jaiswal S, Nair A, Naval R, Jaiswal AK. Major surgical approaches to the posterior third ventricular region: A pictorial review. J Pediatr Neurosci. 2010 Jul;5(2):97-101. doi: 10.4103/1817-1745.76093. No abstract available.
- Background: PubMed 5925731Poppen JL. The right occipital approach to a pinealoma. J Neurosurg. 1966 Dec;25(6):706-10. doi: 10.3171/jns.1966.25.6.0706. No abstract available.
- Background: PubMed 19867913Dandy WE. EXTIRPATION OF THE PINEAL BODY. J Exp Med. 1915 Aug 1;22(2):237-46. doi: 10.1084/jem.22.2.237.
- Background: PubMed 22381843Morgenstern PF, Souweidane MM. Pineal region tumors: simultaneous endoscopic third ventriculostomy and tumor biopsy. World Neurosurg. 2013 Feb;79(2 Suppl):S18.e9-13. doi: 10.1016/j.wneu.2012.02.020. Epub 2012 Feb 10.
- Background: PubMed 34854993Masina R, Ansaripour A, Benes V, Berhouma M, Choque-Velasquez J, Eide PK, Fedorko S, Fleck S, Hernesniemi J, Koziarski A, Majovsky M, Podgorski A, Schroeder H, Teo C, Unterberg AW, Yeung JT, Kolias A, Santarius T. Surgical treatment of symptomatic pineal cysts without hydrocephalus-meta-analysis of the published literature. Acta Neurochir (Wien). 2022 Jan;164(1):61-77. doi: 10.1007/s00701-021-05054-0. Epub 2021 Dec 2.
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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.
Roshdy Abdelaziz Elkhayat, MD, Professor of Neurosurgery contact
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, run by Assiut 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: status not confirmed, as of the sponsor's last update on 23 Mar 2023. 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?
Contact Mohamed Ahmed Alghriany, Master degree in Neurosurgery (+201009252897, vetchalg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
role of surgery and its effect in improving quality of life in children with pineal region tumors (time frame: three years). 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 NCT05781984, which also lists 11 linked publications.
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 23 Mar 2023.