Clinical trial · Observational
Neurocognitive Assessment in Long-Term Survivors of Lymphoma
Neurocognitive Assessment in Long-Term Survivors of Lymphoma: An Observational Study by the Fondazione Italiana Linfomi (FIL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classic Hodgkin Lymphoma | Classic Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Diffuse Large B Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Primary Mediastinal B Cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anthracycline containing regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma
- description
- Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL) in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy. Patients between third and fifth year of follow-up after the end of the first line treatment.
- interventionNames
- Drug: anthracycline containing regimen
Primary outcomes (18)
- measure
- Self-assessed neurocognitive performance
- timeFrame
- The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
- description
- Self-assessed neurocognitive performance will be evaluated through Functional Assessment of Cancer Therapy - Cognitive questionnaire (FACT-Cog Version 3). The FACT-Cog (Version 3) is a self-report questionnaire developed within the measurement system of FACIT.org (Functional Assessment of Chronic Illness Therapy) to assess perceived cognitive functioning in individuals with cancer. The instrument includes 37 items in total, although the most commonly reported total score is based on 33 scored items. Each item is rated on a 5-point Likert scale (0-4) (0 = not at all; 4 = very much / very often, depending on the item). Total score (33-item scoring): Minimum: 0, Maximum: 132. Score interpretation: higher scores indicate better perceived cognitive functioning, lower scores indicate greater perceived cognitive impairment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available