Neurocognitive Assessment in Long-Term Survivors of Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: anthracycline containing regimen.
- Who it may be relevant to
- Registry conditions: Classic Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal B Cell Lymphoma. Basic parameters: 25 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neurocognitive Assessment in Long-Term Survivors of Lymphoma: An Observational Study by the Fondazione Italiana Linfomi (FIL)
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Self-assessed neurocognitive performance [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 7 centers
- 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
Identifiers
NCT: NCT07652476 · FIL_LymDeCo