IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Location status: Recruiting
Location contact
Guido Di Dalmazi, MD
CONTACT
Guido Di Dalmazi, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06801340
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bologna, 40138, Italy
Location status: Recruiting
Guido Di Dalmazi, MD
CONTACT
Guido Di Dalmazi, MD
PRINCIPAL_INVESTIGATOR
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 1 year
This measure will assess the diagnostic ability of specific radiomics-derived parameters, including texture analysis and intensity features, in identifying the nature (benign or malignant) of adrenal masses. The diagnostic performance will be evaluated through sensitivity, specificity.
Time frame: through study completion, an average of 1 years
This measure evaluates the correlation between radiomics-derived imaging parameters and Ki67 proliferation index values. Ki67 values will be assessed as a percentage using immunohistochemical staining, and the correlation will be expressed as a Pearson or Spearman correlation coefficient, depending on data distribution.
Time frame: through study completion, an average of 1 year
This measure evaluates the correlation between radiomics-derived imaging parameters and the Weiss anatomopathologic score. The Weiss score will be determined based on pathological examination, and the association will be reported as a correlation coefficient.
Time frame: through study completion, an average of 1 year
This measure evaluates the relationship between radiomics-derived imaging parameters and the occurrence of distant metastases in patients with adrenal tumors. The occurrence of metastases will be reported as a binary outcome (presence or absence), and the association will be analyzed using logistic regression models or similar statistical methods.
Contact information is provided by the study sponsor or research team.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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