NCT05109858

Skin Toxicity by Oncological Therapies

Observational Study on Skin Toxicity by Oncological Therapies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 334 (actual)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Skin Toxicity

Timeline

• Start date: 2019-03-21
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2021-11-05
• Last updated: 2025-05-06

Locations

20 sites across 1 country: Italy