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Not yet recruiting NCT07315230

Pediatric Midline Post Fossa Tumors Prognostic Factors and Outcomes

Observational Pediatric Tumor Midline Posterior Fossa Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pediatric Tumor, Midline Posterior Fossa Tumors. Basic parameters: 0 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Primary outcome measures

  • Functional Outcome After Surgical Resection of Pediatric Midline Posterior Fossa Tumors [Time frame: 6 months after surgery.]

Eligibility criteria

Inclusion criteria

  • patients less than 18 years old
  • patient with midline posterior fossa tumors
  • patient is fit for surgery

Exclusion criteria

  • patinent older than 18 years old
  • patients with non-midline posterior fossa or other brain tumors.
  • patient is unfit for surgery .
  • Incomplete Data: Missing essential study data.
  • Secondary Malignancy: Metastatic disease.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07315230 · Midline posterior fossa tumors

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗