Neurocognitive Assessment in Long-Term Survivors of Lymphoma

Официальное название

Neurocognitive Assessment in Long-Term Survivors of Lymphoma: An Observational Study by the Fondazione Italiana Linfomi (FIL)

Обзор

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.

Вмешательства

• Препарат anthracycline containing regimen
  Patients in complete remission after treatment with first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy.

Первичные конечные точки

• Self-assessed neurocognitive performance [Срок оценки: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]
• Neurocognitive performance evaluation: Cognitive Status - Mini-Mental State Examination (MMSE) [Срок оценки: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]
• Neurocognitive performance evaluation: Language - Verbal Fluency Test (Phonemic and semanthic) [Срок оценки: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]
• Neurocognitive performance evaluation: Language - Naming of colored Photographs [Срок оценки: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]
• Neurocognitive performance evaluation: Verbal Memory - Digit Span Test (Forward, Backward) [Срок оценки: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]
• Neurocognitive performance evaluation: Verbal Memory - Rey Auditory Verbal Learning Test (Word List 3 Recall) [Срок оценки: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]
• Neurocognitive performance evaluation: Visual-spatial memory/praxic-constructive functions - Corsi Span Test (Forward, Backward) [Срок оценки: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]
• Neurocognitive performance evaluation: Visual-spatial memory/praxic-constructive functions - Rey-Osterrieth Complex Figure Test (ROCF) [Срок оценки: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]
• Neurocognitive performance status: Executive and attentive functions - Trail Making Test (TMT) Part A and B [Срок оценки: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]
• Neurocognitive performance evaluation: Executive and attentive functions - Symbol Digit Modalities Test (SDTM) - Oral Version [Срок оценки: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Patients with CNS disease localization.
• Patients that received brain/neuroaxis radiotherapy.
• Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 7 центров

• Clinica di Ematologia, AOU Ospedali Riuniti — Ancona
• Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncolog — Aviano
• U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II — Bari
• U.O.C. Ematologia Ospedale Civile di Legnano - ASST Ovest Milanese — Legnano
• Ematologia - Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda — Milan
• SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda — Milan
• Ematologia - AOU Policlinico Giaccone — Palermo

Идентификаторы

NCT: NCT07652476 · FIL_LymDeCo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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