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NCT Number: NCT07315230

Pediatric Midline Post Fossa Tumors Prognostic Factors and Outcomes

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.

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Functional Outcome After Surgical Resection of Pediatric Midline Posterior Fossa Tumors

    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).

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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