Skin Toxicity by Oncological Therapies

Skin Toxicity Clinical Trial

— SKINTOX  

Official title:

Observational Study on Skin Toxicity by Oncological Therapies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05109858
• Other study ID #: IRST100.41
• Status: Recruiting
• Start date: March 21, 2019
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2023
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Matelda Medri
• Phone: +390543739100
• Email: matelda.medri[@]irst.emr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 28, 2025
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Toxicity

Locations

Country	Name	City	State
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	AUSL della Romagna - Ospedale "M. Bufalini"	Cesena	Forlì-Cesena
Italy	Università "G. D'Annunzio"	Chieti
Italy	Azienda USL Toscana Centro	Firenze
Italy	ASL di Frosinone - Ospedale "Fabrizio Spaziani"	Frosinone
Italy	IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.	Meldola	Forlì-Cesena
Italy	Ospedale "Franz Tappeiner"	Merano	Bolzano
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	Sapienza Università di Roma - Polo Pontino	Terracina	Latina
Italy	AOU Città della Salute e della Scienza	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years
Primary	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.	5 years
Primary	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.	5 years
Secondary	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).	5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years