Observational Study on Skin Toxicity by Oncological Therapies
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Skin Toxicity
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Enrollment
- 334
- Locations
- 20
- Primary Endpoint
- Evaluation of the severity of skin toxicities related to oncological treatment
- Status
- Completed
- Last Updated
- 12 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Evaluation of the association between skin toxicities and objective response rate(5 years)
- Evaluation of the association between skin toxicities and overall survival(5 years)
- Evaluation of the association between skin toxicities and progression-free survival(5 years)
- Evaluation of the optimal management of skin toxicities related to cancer treatment(5 years)
- Evaluation of the association between skin toxicities and baseline clinical parameters(5 years)