Skin Toxicity by Oncological Therapies (SKINTOX)

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
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Updated on 15 November 2021
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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.

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.

Details
Condition Skin Toxicity
Age 18years - 100years
Clinical Study IdentifierNCT05109858
SponsorIstituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Last Modified on15 November 2021

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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