Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT05109858
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2021-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Skin Toxicity by Oncological Therapies
Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Organization:
Study Overview
Official Title:
Observational Study on Skin Toxicity by Oncological Therapies
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SKINTOX
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: