Actively Recruiting
Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-10-04
420
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed diagnosis of solid tumor
- Able to complete quality of life questionnaires during the study
- Signed written informed consent
- For Group I: Currently receiving anti-PD1/PDL1/CTLA4 or CDK inhibitors for at least 3 months for any cancer type with approved treatment
- For Group II: Eligible to start treatment with anti-PD1/PDL1/CTLA4 or CDK inhibitors approved for their cancer type
You will not qualify if you...
- Under 18 years of age
- Presence of skin diseases or alterations before starting anti-PD1/PDL1 or CDK inhibitor treatment
- Chronic use of steroids
- History of psychiatric disorders or current use of antidepressants
- Refusal to sign written informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Roberto Iacovelli
Roma, Italy, 00168
Actively Recruiting
Research Team
R
Roberto Iacovelli
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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