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NCT04076046 · ClinicalTrials.gov registry record
Multicentric Prospective Validation of the Zurich Pituitary Score
A clinical trial of Pituitary Adenoma, sponsored by University of Zurich.
- Completed
- Registry status
- 408
- Enrollment target
- 10
- Study locations
NCT04076046: Completed study of Pituitary Adenoma, sponsored by University of Zurich.
NCT04076046 is a study of Pituitary Adenoma that has completed, run by University of Zurich. The registered enrollment target is 408 participants, above the 243-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (68% higher). The trial reports 10 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04076046, a study of Pituitary Adenoma, has completed, sponsored by University of Zurich.
- COMPLETED
- Registry status
- 408 participants
- Enrollment target
- 10
- Study locations
Study Summary
Predictive analytics for GTR, EOR and RV are useful in surgical decision-making, particularly whenever there is no unequivocal indication for surgery. Several factors have been shown to have a role in predicting GTR. Among these, the Knosp classification has proven over the years to be a good predictor of GTR. The score is based on the lateral extension of the adenoma in relation the the intracranial bedding of the internal carotid artery. However, recent literature has demonstrated that the Knosp classification suffers from relatively poor interrater agreement. Moreover the classification was conceived in an era when endoscopic techniques were not available: nowadays endoscopic technique allows visualization and possibly also reaching portions of adenoma which at the time when the Knosp classification was introduced were simply not possible. Lastly, the efficacy of the Knosp's score in predicting also EOR and RV has never been tested. Recently a new score - the Zurich Pituitary Score (ZPS) has been proposed at the University Hospital of Zürich (USZ). The score has proved in the examined series to be more powerful than the Knosp classification in predicting GTR, EOR and RV. A good interrater agreement was also demonstrated. The score however, has been validated only in a monocentric setting with a limited number of patients. The aim of this study is to assess the (1) predictive ability of the ZPS for GTR, EOR, and RV, and (2) the inter-rater agreement of the ZPS in an external validation study.
Primary Outcome
Gross Total Resection on magnetic resonance imaging
Conditions Studied
Study Locations (10)
Other
- Department of Neurosurgery, Kepler Universitäts Klinikum - Linz
- Toronto Western Hospital, University of Toronto - Toronto
- Department of Neurosurgery and Neurooncology, First Faculty of Medicine, Charles University and Military University Hospital - Prague
- IRCCS Istituto delle Scienze Neurologiche di Bologna - Bologna
- Azienda Ospedaliera Universitaria Careggi - Florence
- Universita' degli Studi Federico II - Naples
- Reparto di Neurochirurgia, Ospedale di Circolo e Fondazione Macchi, Universita' dell'Insubria - Varese
- CHUV - Lausanne
- Department of Neurosurgery - Zurich
New York
- Donald and Barbara Zucker School of Medicine at Hofstra/Northwell - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2021-12-01 |
What the finished NCT04076046 record still lists
NCT04076046 is an observational study that tracks outcomes without assigning an intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, above the 243-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (68% higher).
The record links to 1 condition, with Pituitary Adenoma appearing as the primary indexed condition, and to 0 interventions.
NCT04076046 lists 10 locations in 2 states (Other, New York).
Frequently Asked Questions
What is clinical trial NCT04076046 about?
NCT04076046 is a clinical study titled "Multicentric Prospective Validation of the Zurich Pituitary Score". Predictive analytics for GTR, EOR and RV are useful in surgical decision-making, particularly whenever there is no unequivocal indication for surgery. Several factors have been shown to have a role in predicting GTR. Among these, the Knosp classification has proven over the years to be a good predic...
What is the current status of trial NCT04076046?
This trial is currently completed. The enrollment target is 408 participants. The study started on 2019-11-01. Estimated completion is 2021-12-01.
What conditions does trial NCT04076046 study?
This clinical trial studies the following conditions: Pituitary Adenoma.
Who is sponsoring clinical trial NCT04076046?
This trial is sponsored by University of Zurich, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04076046 being conducted?
This trial has 10 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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