Analyse of Tumour and Constitutional DNA for the Study of the Determinism in Child Neoplasia
NCT04471961
Familial Cancer, Hematologic Diseases
Montpellier, Occitanie, France
View Trial DetailsNCT Number: NCT07315230
This study will follow children younger than 18 years with midline posterior fossa brain tumors who undergo standard surgical resection at Assiut University Hospital. The aim is to evaluate functional outcome using the modified Rankin Scale and to explore how tumor type, extent of resection, and perioperative factors are associated with postoperative morbidity and survival. Results may help improve risk stratification and guide individualized treatment strategies for pediatric patients with these tumors.
Trial opening soon.
Get Notified0 year–17 year
All sexes
Observational
This is a single-center, prospective, hospital-based observational cohort study conducted in the Neurosurgery Department at Assiut University Hospital. Consecutive pediatric patients (<18 years) with radiologically confirmed midline posterior fossa tumors who are considered fit for surgery will be enrolled after informed consent from parents or legal guardians. Preoperative assessment will include demographic data, clinical presentation, neurological examination, and standardized brain MRI.
All patients will undergo surgical resection according to routine neurosurgical practice, using an operating microscope and standard approaches appropriate to tumor location. Intraoperative details (position, approach, estimated blood loss, complications, and surgeon-assessed extent of resection) will be recorded, and tumor specimens will be sent for histopathological diagnosis. Early postoperative evaluation will document Glasgow Coma Scale, intensive care and hospital stay, and complications such as cerebellar mutism, hydrocephalus, and cranial nerve deficits.
Postoperative imaging (CT or MRI) within 48 hours will be used to classify the extent of resection as gross total, near total, subtotal, or partial. Functional outcome will be assessed using the modified Rankin Scale at approximately 6 months after surgery, with patients categorized as having good (mRS 1-3) or poor (mRS 4-6) outcome. Additional follow-up visits (for example at 3 months, 6 months, and annually when feasible) will document tumor recurrence, need for adjuvant therapies, and long-term neurological sequelae.
The main objective is to evaluate functional and radiological outcomes after surgical management of pediatric midline posterior fossa tumors and to identify prognostic factors that influence morbidity, mortality, and quality of life.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months after surgery.
Assessment of the patient's functional status using the modified Rankin Scale (mRS) after surgical resection of a midline posterior fossa tumor in children, categorized as good outcome (mRS 1-3) or poor outcome (mRS 4-6).
Assiut University
Other
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