Skin Toxicity by Oncological Therapies

NCT ID: NCT05109858

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

334 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-21

Study Completion Date

2025-02-28

Brief Summary

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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

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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

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Skin Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matelda Medri, PhD

Role: STUDY_CHAIR

IRST IRCCS

Locations

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Ospedale "Franz Tappeiner"

Merano, Bolzano, Italy

Site Status

AUSL della Romagna - Ospedale "M. Bufalini"

Cesena, Forlì-Cesena, Italy

Site Status

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

Meldola, Forlì-Cesena, Italy

Site Status

Sapienza Università di Roma - Polo Pontino

Terracina, Latina, Italy

Site Status

Centro di Riferimento Oncologico

Aviano, Pordenone, Italy

Site Status

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Site Status

IRCCS Istituto Tumori "Giovanni Paolo II"

Bari, , Italy

Site Status

Università di Bologna

Bologna, , Italy

Site Status

Università "G. D'Annunzio"

Chieti, , Italy

Site Status

Azienda USL Toscana Centro

Florence, , Italy

Site Status

ASL di Frosinone - Ospedale "Fabrizio Spaziani"

Frosinone, , Italy

Site Status

Azienda Ospedaliera "Papardo"

Messina, , Italy

Site Status

IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

Istituto Europe di Oncologia

Milan, , Italy

Site Status

Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

Napoli, , Italy

Site Status

Università della Campania "Luigi Vanvitelli"

Napoli, , Italy

Site Status

Università Campus Bio-Medico

Roma, , Italy

Site Status

Università degli Studi di Salerno AOU san Giovanni di Dio e Ruggi D'Aragona

Salerno, , Italy

Site Status

Azienda Ospedaliera Universitaria Senese

Siena, , Italy

Site Status

AOU Città della Salute e della Scienza

Torino, , Italy

Site Status

Countries

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Italy

Other Identifiers

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IRST100.41

Identifier Type: -

Identifier Source: org_study_id

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