- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05781984
Role of Surgery in Management of Pineal Region Tumors in Children
March 12, 2023 updated by: Mohamed Ahmed Ibrahim Alghriany, Assiut University
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Ahmed Alghriany, Master degree in Neurosurgery
- Phone Number: +201009252897
- Email: vetchalg@gmail.com
Study Contact Backup
- Name: Roshdy Abdelaziz Elkhayat, MD, Professor of Neurosurgery
- Phone Number: +201223486390
- Email: roushdy.elkhayat@med.aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pediatric population with age of 18 years old or younger diagnosed with pineal region tumor and fit for surgical intervention
Description
Inclusion Criteria:
- All patients with pineal region tumors with age less than or equal to 18 years old and fit for surgical intervention
Exclusion Criteria:
- patients with pineal region tumors older than 18 years old
- and pediatric patients younger than 18 years ild and unfit for surgical intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Li 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.
- Blakeley 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.
- Mottolese 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.
- Mori 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.
- Wang 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.
- Behari 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.
- Poppen 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.
- Dandy WE. EXTIRPATION OF THE PINEAL BODY. J Exp Med. 1915 Aug 1;22(2):237-46. doi: 10.1084/jem.22.2.237.
- Morgenstern 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.
- Masina 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2023
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
January 1, 2024
Study Registration Dates
First Submitted
March 12, 2023
First Submitted That Met QC Criteria
March 12, 2023
First Posted (Actual)
March 23, 2023
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 12, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Pinealoma
Other Study ID Numbers
- Pineal Region Tumors
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.