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NCT07652476
Neurocognitive Assessment in Long-Term Survivors of Lymphoma
Conditions: Classic Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal B Cell Lymphoma
Sex: All
Ages: 25 Years – 55 Years
Healthy volunteers: No
Enrollment: 100
Sponsor: Fondazione Italiana Linfomi - ETS
Location: Clinica di Ematologia, AOU Ospedali Riuniti Ancona
Summary
This is an observational, multicenter, prospective cohort study including patients treated for lymphoma in Italian real-life. Patients eligible for the enrollment in the study will be consecutively included in Italian FIL centers. Patients will be evaluated once during regular follow-up, in the absence of clinical or radiologic signs of disease relapse.
The assessment of neurocognitive functioning will be performed through a panel of tests, both self-administered and individually administered (about 1 hour). The administration of these neuropsychological tests should be done according to a standardized and predefined order. If available, according to local practice, a neuropsychologist may be involved in test administration and in the evaluation of the results.
Based on its observational nature, no treatment change or modification or additional exams or visits will be required because of being enrolled in this study.
Eligibility Criteria
Inclusion Criteria:
* Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL).
* Patients in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy.
* Age ≥ 25 and ≤ 55 at enrollment.
* Patients between third and fifth year of follow-up after the end of the first line treatment.
* Absence of signs or symptoms of disease relapse.
Exclusion Criteria:
* Patients with CNS disease localization.
* Patients that received brain/neuroaxis radiotherapy.
* Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.
Source: ClinicalTrials.gov (NCT07652476). StuddyBuddy aggregates publicly available trial information.