Assessment of Metabolic Complications in Patients With Adrenal Tumors Through Radiological Images

NCT ID: NCT06801340

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-31

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

Conditions

Adrenal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guido Di Dalmazi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Guido Di Dalmazi, MD

Role: CONTACT

guido.didalmazi@unibo.it

+390512143009

Facility Contacts

Guido Di Dalmazi, MD

Role: primary

guido.didalmazi@unibo.it

+390512143009

Other Identifiers

RADIO-AT

Identifier Type: -

Identifier Source: org_study_id