This is a multicenter, retrospective and prospective observational study. The project involves the collection of clinical data of patients treated with oncological therapies, to evaluate skin toxicities related to oncological treatment.
This is a multicenter, retrospective and prospective observational study. The research will include 300 patients treated with clinical practice oncological treatments (approved by Italian Competent Authority, AIFA) from January 2012 to February 2024. Patients will follow the prescribed therapeutic indications according to regular clinical practice and data from their medical records will be collected in a study database. Primary objective of the study is the evaluation of the type, frequency and severity of skin toxicities related to oncological treatment. Secondary objectives are: * Evaluation of the association between skin toxicities due to oncological treatment and drug activity and effectiveness parameters(ORR, PFS, OS); * Evaluation of the association between clinical-pathological features of primary cancer and skin toxicities of oncological treatment; * Evaluation of the optimal management of skin toxicities related to cancer treatment.
Study Type
OBSERVATIONAL
Enrollment
334
Ospedale "Franz Tappeiner"
Merano, Bolzano, Italy
AUSL della Romagna - Ospedale "M. Bufalini"
Cesena, Forlì-Cesena, Italy
Evaluation of the type of skin toxicities related to oncological treatment
Data will be described using absolute and (percentage) relative frequencies calculated for specific types of skin toxicities collected by the participating centers. Specific types of skin toxicities will be defined during dermatologists involved in the study, based on subjects enrolled at each site.
Time frame: 5 years
Evaluation of the frequency of skin toxicities related to oncological treatment
Absolute and (percentage) relative frequencies will be calculated for skin toxicities, stratified considering different oncological treatments.
Time frame: 5 years
Evaluation of the severity of skin toxicities related to oncological treatment
Grade of severity of skin toxicities will be collected: absolute and (percentage) relative frequencies will be calculated for different grades of severity.
Time frame: 5 years
Evaluation of the association between skin toxicities and baseline clinical parameters
A statistical model will be carried out, namely a mathematical relationship between presence of skin toxicities and baseline clinical parameter. Mathematical model will be a logistic regression, in which, independent variable is the presence of skin toxicities while dependent variables are parameters measured at baseline. These parameters could be continuous (for example: age of patients) or categorical (for example: gender or site of disease).
Time frame: 5 years
Evaluation of the association between skin toxicities and objective response rate
Statistical modelling of the association between skin toxicities and objective response rate (ORR) as drug effectiveness parameter. To analyze objective response rate (ORR), proportion of patients with complete and partial response will be calculated, globally for all patients and considering different subgroup of treatment type.
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IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, Forlì-Cesena, Italy
Sapienza Università di Roma - Polo Pontino
Terracina, Latina, Italy
Centro di Riferimento Oncologico
Aviano, Pordenone, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, Italy
Università di Bologna
Bologna, Italy
Università "G. D'Annunzio"
Chieti, Italy
Azienda USL Toscana Centro
Florence, Italy
...and 10 more locations
Time frame: 5 years
Evaluation of the association between skin toxicities and progression-free survival
Statistical modelling of the association between skin toxicities and progression-free survival (PFS) as drug effectiveness parameter. To evaluate progression-free survival, difference between date of start therapy and date of disease progression (or death) will be calculated.
Time frame: 5 years
Evaluation of the association between skin toxicities and overall survival
Statistical modelling of the association between skin toxicities and overall survival (OS) as drug effectiveness parameter. To evaluate overall survival, difference between date of start therapy and date of or death will be calculated. Time for patients without event (progression of disease or death) will be considered from date of start therapy and date of last contact.
Time frame: 5 years
Evaluation of the optimal management of skin toxicities related to cancer treatment
Data related to management of skin toxicities will be described using absolute and (percentage) relative frequencies calculated for specific types of skin toxicities collected by the participating centers.
Time frame: 5 years