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COMPLETED

Multicentric Prospective Validation of the Zurich Pituitary Score

NCT04076046 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 408 participants
Start Date 2019-11-01
Est. Completion 2021-12-01

Sponsor

University of Zurich

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04076046

The ClinicalTrials.gov registry entry for NCT04076046 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 408 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Zurich, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pituitary Adenoma appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04076046 reports 10 study locations spanning 2 distinct geographic areas — top geographies include Other, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT04076046?

This trial is sponsored by University of Zurich, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial