Skin Toxicity by Oncological Therapies (SKINTOX)

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

Status: Completed

Conditions: Skin Toxicity

Study type: Observational

Funder types: Other

Identifiers

NCT05109858

IRST100.41

Details and patient eligibility

About

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.

Full 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.

Enrollment: 334 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.