Clinical trial NCT06801340: Assessment of Metabolic Complications in Patients With Adrenal Tumors Through Radiological Images
Official title: Assessment of Metabolic Complications in Patients With Adrenal Tumors Through Radiological Images
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adrenal Cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the study will be enrolled at participating centers, selected from those who meet the inclusion/exclusion criteria.

Brief summary: 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

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

Primary outcomes:
measure: Diagnostic Accuracy of Radiomics-Derived Parameters for Differentiating Benign and Malignant Adrenal Masses
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Association of Radiomics-Derived Parameters with Ki67 Values
timeFrame: through study completion, an average of 1 years
measure: Association of Radiomics-Derived Parameters with Weiss' Anatomopathologic Score
timeFrame: through study completion, an average of 1 year
measure: Association of Radiomics-Derived Parameters with Occurrence of Distant Metastasis
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Guido Di Dalmazi, MD
role: PRINCIPAL_INVESTIGATOR
References: