Skin Toxicity by Oncological Therapies
- Conditions
- Skin Toxicity
- Registration Number
- NCT05109858
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 334
- Patient who have signed informed consent.
- Consecutive retrospective patients and prospective patients treated with new clinical practice oncological treatments (approved by AIFA) from January 2012 to February 2024
- Male or female, age ≥18 years.
Participation in another clinical trial with any investigational drug.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the severity of skin toxicities related to oncological treatment 5 years Grade of severity of skin toxicities will be collected: absolute and (percentage) relative frequencies will be calculated for different grades of severity.
Evaluation of the frequency of skin toxicities related to oncological treatment 5 years Absolute and (percentage) relative frequencies will be calculated for skin toxicities, stratified considering different oncological treatments.
Evaluation of the type of skin toxicities related to oncological treatment 5 years 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.
- Secondary Outcome Measures
Name Time Method Evaluation of the association between skin toxicities and objective response rate 5 years 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.
Evaluation of the association between skin toxicities and overall survival 5 years 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.
Evaluation of the association between skin toxicities and progression-free survival 5 years 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.
Evaluation of the optimal management of skin toxicities related to cancer treatment 5 years 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.
Evaluation of the association between skin toxicities and baseline clinical parameters 5 years 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).
Trial Locations
- Locations (20)
Ospedale "Franz Tappeiner"
🇮🇹Merano, Bolzano, Italy
AUSL della Romagna - Ospedale "M. Bufalini"
🇮🇹Cesena, Forlì-Cesena, Italy
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
🇮🇹Firenze, Italy
ASL di Frosinone - Ospedale "Fabrizio Spaziani"
🇮🇹Frosinone, Italy
Azienda Ospedaliera "Papardo"
🇮🇹Messina, Italy
IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Istituto Europe di Oncologia
🇮🇹Milano, Italy
Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
🇮🇹Napoli, Italy
Università della Campania "Luigi Vanvitelli"
🇮🇹Napoli, Italy
Università Campus Bio-Medico
🇮🇹Roma, Italy
Università degli Studi di Salerno AOU san Giovanni di Dio e Ruggi D'Aragona
🇮🇹Salerno, Italy
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
AOU Città della Salute e della Scienza
🇮🇹Torino, Italy