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

Study acronym: SkinHealth
StatusUnknown
PhaseNot specified
Started
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Record status
This record was last updated October 4, 2024 (before its estimated July 22, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary completion date: Jul 22, 2024 to Jul 22, 2025
    • Study completion date: Sep 22, 2024 to Sep 22, 2025
    • Site contact updated
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary endpoints: 2 to 3
    • Primary completion date: May 22, 2024 to Jul 22, 2024
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
    • Study title shortened, about 4 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05878964
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)		 Lung Cancer, Breast Cancer, Kidney Cancer, Bladder Cancer, Gastric Cancer, Skin Cancer, Melanoma, Head Neck Cancer
Related terms Breast Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Lung Neoplasms, Melanoma, Skin Neoplasms, Stomach Neoplasms, Urinary Bladder Neoplasms
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov