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NCT Number: NCT05109858

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.

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Key information

Conditions

Skin Toxicity

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale "Franz Tappeiner", Merano, Bolzano, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

Participation in another clinical trial with any investigational drug.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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. 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.

Sponsors and collaborators

Lead sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Other

Registry information

Official study title

Observational Study on Skin Toxicity by Oncological Therapies

Acronym: SKINTOX

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2021
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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