Cambridge Prospective Cohort Study of Surgical Treatment of Patients with Symptomatic Pineal Cyst

Study acronym: CamProS-PC

Short Tile: Cambridge Prospective Cohort Study of Surgical Treatment of Patients with Symptomatic Pineal Cyst

Full Scientific Title: Assessment of changes in quality of life and symptoms over time in patients with symptomatic pineal cyst treated with surgery or conservatively – a prospective observational cohort study

Sponsor: Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK

Study Participants: Patients with symptomatic pineal cysts (SPCs)

Planned Sample Size: 40 surgically treated patients and all conservatively treated patients at the same period

Planned Study Period: Up to 5 years

Primary Objective: Assessment of the impact of surgery on quality of life, specifically patients’ role functioning at one year after resection of symptomatic pineal cyst

Secondary Objectives:

1. Assessment of all aspects of quality of life as defined by the EORTC QLQ-C30 questionnaire at 1 year and also at 2 and 3 years after surgery.
2. Assessment of symptoms at 1 year and also at 2 and 3 years after surgery.
3. Assessment of all aspects of quality of life and symptoms in patients who did not undergo surgery (= conservative management) at the time of diagnosis and at 1, 2 and 3 years after joining the study; and investigation the differences at baseline and follow up between those treated surgically and conservatively.
4. Comparison of objective neuropsychological assessments before the operation and at 1 year after surgery.
5. Development of a model to identify anatomical (based in MRI scans) and clinical (symptoms) predictors of improvement of QoL after surgery for SPC
   

Study design: Prospective observational cohort study

Interventions: No interventions. This is an observational study

Study type: Safety, Efficacy

Participant inclusion criteria:

• age ≥18 years
• presence of a PC of size >10mm
• presence of severe symptoms consistent with the syndrome of nhSPC, defined as ≥6/10 on Eide- Ringstad pineal cyst symptom severity scale (Eide & Ringstad Acta Neurochirurgica, 2017)
• ≥6 months of conservative treatment without improvement
  

Participant exclusion criteria:

• radiological evidence of ventriculomegaly
• other diagnosis of CNS pathology
• precious intracranial neurosurgical intervention
  

IRAS Project ID: 292313

REC Reference: 21/NI/0120

Health Research Authority Approval Letter:

Recruitment start date: July 2021

Recruitment end date: May 2023

Number of patients recruited: 40

Study Protocol:

2022 Amendment:

Study documents

Participant Information Sheet:

Participant Consent:

Quality of life questionnaire – EORTC-QLQ-C30 (used at each time point, i.e. before the operation, at 3 months, 12 months, 24 months etc after the operation )

Pre-operative symptom questionnaire:

Post-operative questionnaires:

Current status (last update 6/12/2024): data analysis

Related publications:

Harding J, Masina R, Hill A, Ansanipour A, Steele A, Kolias A, Santarius T: International web-based survey of patients with non-hydrocephalic symptomatic pineal cysts, Acta Neurochirurgica, 166(1):509, 2024

Masina R, Ansaripour A, Beneš V, Berhouma M, Choque-Velasquez J, Eide PK, Fedorko S, Fleck S, Hernesniemi J, Koziarski A, Májovský 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 Neurochirurgica, 164(1):61-77, 2022