Skin Toxicity by Oncological Therapies (SKINTOX)

Observational Study on Skin Toxicity by Oncological Therapies

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.

Study Overview

• Status: Completed
• Conditions: Skin Toxicity

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.

• Study Type: Observational
• Enrollment (Actual): 334

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • IRCCS Istituto Tumori "Giovanni Paolo II"
  • Bari, Italy, 70124
    • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
  • Bologna, Italy, 40138
    • Universita di Bologna
  • Chieti, Italy, 66100
    • Università "G. D'Annunzio"
  • Firenze, Italy, 50125
    • Azienda USL Toscana Centro
  • Frosinone, Italy, 03100
    • ASL di Frosinone - Ospedale "Fabrizio Spaziani"
  • Messina, Italy, 98158
    • Azienda Ospedaliera "Papardo"
  • Milano, Italy, 20141
    • Istituto Europe di Oncologia
  • Milano, Italy, 20133
    • IRCCS Istituto Nazionale dei Tumori
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
  • Napoli, Italy, 80131
    • Università della Campania "Luigi Vanvitelli"
  • Roma, Italy, 00128
    • Università Campus Bio-Medico
  • Salerno, Italy, 84131
    • Università degli Studi di Salerno AOU san Giovanni di Dio e Ruggi D'Aragona
  • Siena, Italy, 53100
    • Azienda Ospedaliera Universitaria Senese
  • Torino, Italy, 10026
    • AOU Città della Salute e della Scienza
  • Bolzano
    • Merano, Bolzano, Italy, 39012
      • Ospedale "Franz Tappeiner"
  • Forlì-Cesena
    • Cesena, Forlì-Cesena, Italy, 47521
      • AUSL della Romagna - Ospedale "M. Bufalini"
    • Meldola, Forlì-Cesena, Italy, 47014
      • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
  • Latina
    • Terracina, Latina, Italy, 04019
      • Sapienza Università di Roma - Polo Pontino
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Centro Di Riferimento Oncologico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with any oncological therapy (approved by AIFA) as per clinical practice, from 2012 to 2024.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
• Investigators: Study Chair: Matelda Medri, PhD, Irst Irccs

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: skin toxicities; oncological therapies
• Other Study ID Numbers: IRST100.41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No