Skin ToxicitySKINTOXNCT05109858
Skin Toxicity by Oncological Therapies
An observational study of Skin Toxicity, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 20 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Skin Toxicity
- How many people
- 334 participants
- Where
- 20 sitesItaly
- Study dates
- 21 Mar 2019to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with any oncological therapy (approved by AIFA) as per clinical practice, from 2012 to 2024.
Who may be able to join
- 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.
Who cannot join
- Participation in another clinical trial with any investigational drug.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Centro di Riferimento Oncologico
Aviano, Pordenone, 33081
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, 70124
Università di Bologna
Bologna, 40138
AUSL della Romagna - Ospedale "M. Bufalini"
Cesena, Forlì-Cesena, 47521
Università "G. D'Annunzio"
Chieti, 66100
Azienda USL Toscana Centro
Florence, 50125
ASL di Frosinone - Ospedale "Fabrizio Spaziani"
Frosinone, 03100
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, Forlì-Cesena, 47014
Ospedale "Franz Tappeiner"
Merano, Bolzano, 39012
Azienda Ospedaliera "Papardo"
Messina, 98158
IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Istituto Europe di Oncologia
Milan, 20141
Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
Naples, 80131
Università della Campania "Luigi Vanvitelli"
Naples, 80131
Università Campus Bio-Medico
Roma, 00128
Università degli Studi di Salerno AOU san Giovanni di Dio e Ruggi D'Aragona
Salerno, 84131
Azienda Ospedaliera Universitaria Senese
Siena, 53100
Sapienza Università di Roma - Polo Pontino
Terracina, Latina, 04019
AOU Città della Salute e della Scienza
Torino, 10026
About this study
Official title: Observational Study on Skin Toxicity by Oncological Therapies
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.
Read the 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
- Keywords
- skin toxicities, oncological therapies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 years
Secondary outcomes (5)
Evaluation of the association between skin toxicities and baseline clinical parameters
A statistical model will be carried out, namely a mathematical relationship between presence of skin toxicities and baseline clinical parameter. Mathematical model will be a logistic regression, in which, independent variable is the presence of skin toxicities while dependent variables are parameters measured at baseline. These parameters could be continuous (for example: age of patients) or categorical (for example: gender or site of disease).
Measured: 5 years
Evaluation of the association between skin toxicities and objective response rate
Statistical modelling of the association between skin toxicities and objective response rate (ORR) as drug effectiveness parameter. To analyze objective response rate (ORR), proportion of patients with complete and partial response will be calculated, globally for all patients and considering different subgroup of treatment type.
Measured: 5 years
Evaluation of the association between skin toxicities and progression-free survival
Statistical modelling of the association between skin toxicities and progression-free survival (PFS) as drug effectiveness parameter. To evaluate progression-free survival, difference between date of start therapy and date of disease progression (or death) will be calculated.
Measured: 5 years
Evaluation of the association between skin toxicities and overall survival
Statistical modelling of the association between skin toxicities and overall survival (OS) as drug effectiveness parameter. To evaluate overall survival, difference between date of start therapy and date of or death will be calculated. Time for patients without event (progression of disease or death) will be considered from date of start therapy and date of last contact.
Measured: 5 years
Evaluation of the optimal management of skin toxicities related to cancer treatment
Data related to management of skin toxicities will be described using absolute and (percentage) relative frequencies calculated for specific types of skin toxicities collected by the participating centers.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start21 Mar 2019
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matelda Medri, PhD, Study chair, IRST IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109858
- Sponsor's protocol ID
- IRST100.41
- Acronym
- SKINTOX
- Status last verified
- May 2025
- First submitted
- 16 Sep 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Skin Toxicity by Oncological Therapies
- ClinicalTrials.gov ID
- NCT05109858
- Acronym / sponsor ID
- SKINTOX / IRST100.41
- Conditions
- Skin Toxicity
- Keywords
- skin toxicities, oncological therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with any oncological therapy (approved by AIFA) as per clinical practice, from 2012 to 2024.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participation in another clinical trial with any investigational drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the type of skin toxicities related to oncological treatment
Time frame: 5 years
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.
Evaluation of the frequency of skin toxicities related to oncological treatment
Time frame: 5 years
Absolute and (percentage) relative frequencies will be calculated for skin toxicities, stratified considering different oncological treatments.
Evaluation of the severity of skin toxicities related to oncological treatment
Time frame: 5 years
Grade of severity of skin toxicities will be collected: absolute and (percentage) relative frequencies will be calculated for different grades of severity.
5 secondary outcomes
Evaluation of the association between skin toxicities and baseline clinical parameters
Time frame: 5 years
Evaluation of the association between skin toxicities and objective response rate
Time frame: 5 years
Evaluation of the association between skin toxicities and progression-free survival
Time frame: 5 years
Evaluation of the association between skin toxicities and overall survival
Time frame: 5 years
Evaluation of the optimal management of skin toxicities related to cancer treatment
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matelda Medri, PhD study chair
IRST IRCCS
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Toxicity, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the type of skin toxicities related to oncological treatment (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.