Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.

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Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05878964
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Roberto Iacovelli
Principal Investigator Affiliation	Fondazione Policlinico Universitario A. Gemelli, IRCCS
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lung Cancer, Breast Cancer, Kidney Cancer, Bladder Cancer, Gastric Cancer, Skin Cancer, Melanoma, Head Neck Cancer

Arms & Interventions

Arms

: Group 1

All patients affected by solid tumors already in treatment with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors.

: Group 2

All patients affected by solid tumors already eligible for treatment with anti-PD1/PDL1 or cyclin-dependent kinase (CDK) inhibitors.

Interventions

Other: - EQ-5D-5L questionnaire

Quality of life evaluation questionnaire

Other: - FACT-G (Functional Assessment of Cancer Therapy - General)

Quality of life evaluation questionnaire

Other: - FACT-EGFRI-18 (Functional Assessment of Cancer Therapy - Epidermal Growth Factor Inhibitors 18 Item)

Self reported evaluation of cutaneous toxicity questionnaire.

Contact a Trial Team

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