Asrem, Italy

  • Acalabrutinib Real World Italian obSErvational Study -ARISE

    Study design: This is an Italian non-interventional / observational, multicenter, longitudinal secondary data usage study based on a retrospective cohort of patients with CLL, who initiated treatment with acalabrutinib between 1st May 2021 and 30th April 2022 (index date), regardless of the treatment status at the time of inclusion. Each patient will be followed-up up to 5 years since the last enrolled patient index date (therefore for a maximum of 72 months). Five data extraction timepoints are planned for the investigators to proceed with secondary data extraction from patients' medical records and data entry into the electronic case report form (eCRFs). Data Source(s): Source documents (paper or electronic) are those in which patient data are recorded and documented for the first time as part of patients' path of care (e.g., patient's hospital records, pharmacy dispensing records). A standardized, validated eCRF will be developed to capture data extracted from source documents at each participating site. Study Population: All consecutive adult patients with CLL who initiated treatment with acalabrutinib over the period between 1st May 2021 and 30th April 2022, according to Italian legislation dlg 219/2006 art.125. Outcome(s): The primary outcome is the time to acalabrutinib discontinuation (defined as time in days from start date of acalabrutinib treatment to end date of acalabrutinib treatment). Secondary outcomes include: Time from diagnosis to start of acalabrutinib, immunophenotype, CLL clinical stage (Binet), FISH profile, mutations, karyotype, CLL treatments before acalabrutinib, socio-demographic characteristics at baseline, medical history, concomitant treatments, COVID-19 prophylaxis and treatments, constitutional symptoms, patient clinical status, ECG/TTE, complete blood count with differential, serum chemistry, HIV and Hepatitis serology, active haemolysis, time to acalabrutinib discontinuation, acalabrutinib treatment (dosage, relative changes, temporary interruption/permanent discontinuation). Exploratory outcomes include: Time to progression, Time to death, CLL status (according to iwCLL), Time to Next Treatment, Time to progression on next line treatment, reasons for ending of CLL treatments following acalabrutinib discontinuation, visits and hospitalizations due to CLL or suspected ADR during acalabrutinib treatment.

    Phase

    N/A

    Span

    343 weeks

    Sponsor

    AstraZeneca

    Oristano

    Recruiting

  • Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

    For each unit involved, it will be collected these data : - Structural and organizational data of the Rehabilitation Units for Severe Acquired Brain Injuries; - Detailed information on patients upon entering Rehabilitation Units for Severe Acquired Brain Injuries; - Detailed information on patients, re-evaluated 4 months after the acute event Statistical models will be implemented, in order to identify prognostic factors that could predict the probability to observe three events, which represent objectives of the rehabilitation process: decannulation, trunk control and total feeding by os. These events should be evaluated four months after the acute episode.

    Phase

    N/A

    Span

    182 weeks

    Sponsor

    Mario Negri Institute for Pharmacological Research

    Oristano

    Recruiting

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