Clinical trial NCT05109858: Skin Toxicity by Oncological Therapies
Official title: Observational Study on Skin Toxicity by Oncological Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Toxicity
Keywords: skin toxicities
oncological therapies
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with any oncological therapy (approved by AIFA) as per clinical practice, from 2012 to 2024.

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.

Eligibility criteria: Inclusion Criteria:

1. Patient who have signed informed consent.
2. Consecutive retrospective patients and prospective patients treated with new clinical practice oncological treatments (approved by AIFA) from January 2012 to February 2024
3. Male or female, age ≥18 years.

Exclusion Criteria:

Participation in another clinical trial with any investigational drug.

Primary outcomes:
measure: Evaluation of the type of skin toxicities related to oncological treatment
timeFrame: 5 years
measure: Evaluation of the frequency of skin toxicities related to oncological treatment
timeFrame: 5 years
measure: Evaluation of the severity of skin toxicities related to oncological treatment
timeFrame: 5 years
Secondary outcomes:
measure: Evaluation of the association between skin toxicities and baseline clinical parameters
timeFrame: 5 years
measure: Evaluation of the association between skin toxicities and objective response rate
timeFrame: 5 years
measure: Evaluation of the association between skin toxicities and progression-free survival
timeFrame: 5 years
measure: Evaluation of the association between skin toxicities and overall survival
timeFrame: 5 years
measure: Evaluation of the optimal management of skin toxicities related to cancer treatment
timeFrame: 5 years
Other outcomes:
Locations:
city: Merano
country: Italy
facility: Ospedale "Franz Tappeiner"
state: Bolzano
city: Cesena
country: Italy
facility: AUSL della Romagna - Ospedale "M. Bufalini"
state: Forlì-Cesena
city: Meldola
country: Italy
facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
state: Forlì-Cesena
city: Terracina
country: Italy
facility: Sapienza Università di Roma - Polo Pontino
state: Latina
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
state: Pordenone
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
city: Bari
country: Italy
facility: IRCCS Istituto Tumori "Giovanni Paolo II"
city: Bologna
country: Italy
facility: Università di Bologna
city: Chieti
country: Italy
facility: Università "G. D'Annunzio"
city: Firenze
country: Italy
facility: Azienda USL Toscana Centro
city: Frosinone
country: Italy
facility: ASL di Frosinone - Ospedale "Fabrizio Spaziani"
city: Messina
country: Italy
facility: Azienda Ospedaliera "Papardo"
city: Milano
country: Italy
facility: IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: Istituto Europe di Oncologia
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
city: Napoli
country: Italy
facility: Università della Campania "Luigi Vanvitelli"
city: Roma
country: Italy
facility: Università Campus Bio-Medico
city: Salerno
country: Italy
facility: Università degli Studi di Salerno AOU san Giovanni di Dio e Ruggi D'Aragona
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza
Study officials:
affiliation: IRST IRCCS
name: Matelda Medri, PhD
role: STUDY_CHAIR
References: