NCT05878964 Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.
| NCT ID | NCT05878964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 420 participants |
| Start Date | 2023-05-22 |
| Primary Completion | 2025-07-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 420 participants in total. It began in 2023-05-22 with a primary completion date of 2025-07-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aim to investigate the relationship between cutaneous adverse events and quality of life in patients taking immune check point inhibitor or cyclin-dependent kinase (CDK) 4 and 6 inhibitors by two steps. In the first one, it will be investigated the relationship between the skin toxicity related to the use selected therapies and the quality of life of patients already receiving these therapies for treatment of their cancer. In the second one, it will be evaluated the relationship between skin toxicity and quality of life over three months of treatment in patients initially naïve for selected therapies. Cancer included in the analysis are NSCLC, renal cancer, gastric cancer, breast cancer, bladder cancer, melanoma, squamous cell carcinoma of the head and neck.
Eligibility Criteria
Inclusion Criteria: (for all Groups) 1. Age ≥ 18 years. 2. Histological diagnosis of solid tumor. 3. Patient able to complete the questionnaires submitted during the study. 4. Signed written informed consent. (for Group I) Patients already under treatment for at least three months with anti-PD1/PDL1/ CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor. (for Group II) Patients eligible for treatment with anti-PD1/PDL1/ CTLA4 or cyclin-dependent kinase (CDK) inhibitors for any type of cancer. Treatment considered for each cancer are only those approved by AIFA for each tumor. Exclusion Criteria (for all Groups): 1. Age \< 18 y.o. 2. Skin diseases or alterations present before the beginning of anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors. 3. Chronic use of steroids. 4. Previous psychiatric disorders or patients taking antidepressant. 5. Refusal to sign written informed consent.
Contact & Investigator
Roberto Iacovelli
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT05878964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05878964 currently recruiting?
Yes, NCT05878964 is actively recruiting participants. Contact the research team at roberto.iacovelli@policlinicogemelli.it for enrollment information.
Where is the NCT05878964 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT05878964 clinical trial?
NCT05878964 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Roberto Iacovelli at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 420 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.