Assessment of Metabolic Complications in Patients With Adrenal Tumors Through Radiological Images
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: Adrenal Cancer. Basic parameters: from 18 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
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Retrospective study based on data already available at each Center. Pseudonymized CT images of each patient in DICOM format will be sent from each center to the Coordinating Center to perform radiomics analysis.
Detailed description
Retrospective study based on data already available at each Center. Participating Centers will identify patients based on shared inclusion/exclusion criteria. Pseudonymized CT images of each patient in DICOM format will be sent from each center to the Coordinating Center to perform radiomics analysis. Images will be transferred via File Transfer Protocol while respecting the anonymity of enrolled patients. Images will be deposited in a dedicated study folder created by the AOUBO ICT Service. Images will be accessible only to the Investigator and Principal Investigator and/or their delegates via personalized credentials, which can be accessed only from IRCCS AOUBO computers and facilities. The folder to which the images will be transferred will be accessible only to the Principal Investigator and his/her Collaborators through customized private credentials usable only through IRCCS AOUBO networks, computers and facilities. Radiomics, which will be applied to existing CT images, will in no way affect the care pathway of patients
Primary outcome measures
- Diagnostic Accuracy of Radiomics-Derived Parameters for Differentiating Benign and Malignant Adrenal Masses [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (3)
- Association of Radiomics-Derived Parameters with Ki67 Values [Time frame: through study completion, an average of 1 years]
- Association of Radiomics-Derived Parameters with Weiss' Anatomopathologic Score [Time frame: through study completion, an average of 1 year]
- Association of Radiomics-Derived Parameters with Occurrence of Distant Metastasis [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Patients with adrenal tumor who underwent adrenectomy surgery from 1-1-2000 to 30-5-2023, performed according to clinical necessity and indications of international guidelines,with availability of histologic diagnosis or adrenal tumor that did not undergo adrenectomy surgery with diagnosis of benignity confirmed by radiologic stability at 6-12 months after first finding(as indicated in guidelines)
- Availability of radiological images in DICOM format of abdominal CT scan in which the adrenal tumor is first described, obtained on the date of first evaluation at the participating center (necessarily before surgery for patients undergoing adrenectomy)
- Signature of informed consent
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06801340 · RADIO-AT