Skin Toxicity by Oncological Therapies (SKINTOX)

March 1, 2023 updated by: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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

Recruiting

Conditions

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 (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Centro di Coordinamento Studi IRST
  • Phone Number: +390544285075
  • Email: cc.ubsc@irst.emr.it

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
        • Contact:
      • Bari, Italy, 70124
      • Bologna, Italy, 40138
      • Chieti, Italy, 66100
        • Recruiting
        • Università "G. D'Annunzio"
        • Contact:
      • Firenze, Italy, 50125
      • Frosinone, Italy, 03100
      • Messina, Italy, 98158
      • Milano, Italy, 20133
      • Milano, Italy, 20141
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
        • Contact:
      • Napoli, Italy, 80131
        • Recruiting
        • Università della Campania "Luigi Vanvitelli"
        • Contact:
      • Roma, Italy, 00128
      • Salerno, Italy, 84131
        • Recruiting
        • Università degli Studi di Salerno AOU san Giovanni di Dio e Ruggi D'Aragona
        • Contact:
      • Siena, Italy, 53100
        • Recruiting
        • Azienda Ospedaliera Universitaria Senese
        • Contact:
      • Torino, Italy, 10026
    • Bolzano
      • Merano, Bolzano, Italy, 39012
    • Forlì-Cesena
      • Cesena, Forlì-Cesena, Italy, 47521
      • Meldola, Forlì-Cesena, Italy, 47014
        • Recruiting
        • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.
        • Contact:
    • Latina
      • Terracina, Latina, Italy, 04019
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Recruiting
        • Centro di Riferimento Oncologico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
5 years
Evaluation of the frequency of skin toxicities related to oncological treatment
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: 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).
5 years
Evaluation of the association between skin toxicities and objective response rate
Time Frame: 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.
5 years
Evaluation of the association between skin toxicities and progression-free survival
Time Frame: 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.
5 years
Evaluation of the association between skin toxicities and overall survival
Time Frame: 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.
5 years
Evaluation of the optimal management of skin toxicities related to cancer treatment
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Investigators

  • Study Chair: Matelda Medri, PhD, Irst Irccs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2019

Primary Completion (Anticipated)

February 29, 2024

Study Completion (Anticipated)

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)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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