NCT05109858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

5.9 years

First QC Date

September 16, 2021

Last Update Submit

May 5, 2025

Conditions

Skin Toxicity

Keywords

skin toxicitiesoncological therapies

Outcome Measures

Primary Outcomes (3)

  • Evaluation of the type of skin toxicities related to oncological treatment

    Data will be described using absolute and (percentage) relative frequencies calculated for specific types of skin toxicities collected by the participating centers. Specific types of skin toxicities will be defined during dermatologists involved in the study, based on subjects enrolled at each site.

    5 years

  • Evaluation of the frequency of skin toxicities related to oncological treatment

    Absolute and (percentage) relative frequencies will be calculated for skin toxicities, stratified considering different oncological treatments.

    5 years

  • Evaluation of the severity of skin toxicities related to oncological treatment

    Grade of severity of skin toxicities will be collected: absolute and (percentage) relative frequencies will be calculated for different grades of severity.

    5 years

Secondary Outcomes (5)

  • Evaluation of the association between skin toxicities and baseline clinical parameters

    5 years

  • Evaluation of the association between skin toxicities and objective response rate

    5 years

  • Evaluation of the association between skin toxicities and progression-free survival

    5 years

  • Evaluation of the association between skin toxicities and overall survival

    5 years

  • Evaluation of the optimal management of skin toxicities related to cancer treatment

    5 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with any oncological therapy (approved by AIFA) as per clinical practice, from 2012 to 2024.

You may qualify if:

  • 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.

You may not qualify if:

  • Participation in another clinical trial with any investigational drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Ospedale "Franz Tappeiner"

Merano, Bolzano, 39012, Italy

Location

AUSL della Romagna - Ospedale "M. Bufalini"

Cesena, Forlì-Cesena, 47521, Italy

Location

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

Meldola, Forlì-Cesena, 47014, Italy

Location

Sapienza Università di Roma - Polo Pontino

Terracina, Latina, 04019, Italy

Location

Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, 70124, Italy

Location

IRCCS Istituto Tumori "Giovanni Paolo II"

Bari, 70124, Italy

Location

Università di Bologna

Bologna, 40138, Italy

Location

Università "G. D'Annunzio"

Chieti, 66100, Italy

Location

Azienda USL Toscana Centro

Florence, 50125, Italy

Location

ASL di Frosinone - Ospedale "Fabrizio Spaziani"

Frosinone, 03100, Italy

Location

Azienda Ospedaliera "Papardo"

Messina, 98158, Italy

Location

IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Istituto Europe di Oncologia

Milan, 20141, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

Napoli, 80131, Italy

Location

Università della Campania "Luigi Vanvitelli"

Napoli, 80131, Italy

Location

Università Campus Bio-Medico

Roma, 00128, Italy

Location

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

Salerno, 84131, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

AOU Città della Salute e della Scienza

Torino, 10026, Italy

Location

Study Officials

  • Matelda Medri, PhD

    IRST IRCCS

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2021

First Posted

November 5, 2021

Study Start

March 21, 2019

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

May 6, 2025

Record last verified: 2025-05

Locations

IT(20)