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Neurocognitive Assessment in Long-Term Survivors of Lymphoma (FIL_LymDeCo)

2026年6月17日 更新者：Fondazione Italiana Linfomi - ETS

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Iolanda Uffici Studi FIL
  • 电话号码：+390131033153
  • 邮箱：startup@filinf.it

学习地点

  • 意大利
      • Ancona、意大利
      • Aviano、意大利
        • Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
        • 接触：
      • Bari、意大利
        • U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
        • 接触：
      • Legnano、意大利
      • Milan、意大利
        • SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
        • 接触：
      • Milan、意大利
      • Palermo、意大利

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

取样方法

概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma

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.
药品：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Self-assessed neurocognitive performance
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
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.
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)
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Cognitive status will be assessed using the Mini-Mental State Examination (MMSE). Unit of Measure: Total score (points) Range: 0 to 30 Interpretation: Higher scores indicate better cognitive performance.
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)
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Language function will be assessed using a Verbal Fluency Test (phonemic and semantic). Unit of Measure: Number of correct words generated within the allotted time Range: No fixed maximum value Interpretation: Higher scores indicate better language performance.
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
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Language function assessed through a picture-naming task in which participants are asked to correctly name colored photographs depicting common objects, people, or scenes. Performance is evaluated based on the accuracy of responses, reflecting lexical retrieval, semantic processing, and expressive language abilities. Higher scores indicate better language performance.
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)
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Verbal memory and working memory assessed using the Digit Span Test. Participants are required to recall and repeat sequences of digits in the same order (Forward Digit Span) and in reverse order (Backward Digit Span). Performance is evaluated based on the number of correctly recalled sequences and/or total score achieved, reflecting attention, short-term verbal memory, and working memory capacity. Higher scores indicate better cognitive performance.
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)
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Verbal memory will be assessed using Word List 3 recall from the Rey Auditory Verbal Learning Test (RAVLT). Unit of Measure: Number of words correctly recalled Range: 0 to 15 Interpretation: Higher scores indicate better verbal memory performance.
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)
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Visual-spatial short-term memory and working memory assessed using the Corsi Span Test. Participants are required to reproduce sequences of spatial locations in the same order (Forward Corsi Span) and in reverse order (Backward Corsi Span). Performance is evaluated based on the number of correctly reproduced sequences and/or span length achieved, reflecting visual-spatial memory, spatial working memory, and praxic-constructive abilities. Higher scores indicate better cognitive performance.
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)
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Visual memory will be assessed using the delayed recall condition of the Rey-Osterrieth Complex Figure Test (ROCF). Unit of Measure: Total score (points) Range: 0 to 36 Interpretation: Higher scores indicate better visual memory performance.
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
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Executive and attentive functions will be assessed using Part A and B of the Trail Making Test (TMT). Unit of Measure: Completion time (seconds) Range: Continuous variable (no fixed maximum) Interpretation: Lower scores indicate better performance.
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
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Executive and attentive functions will be assessed using the oral version of the Symbol Digit Modalities Test (SDMT). Unit of Measure: Number of correct substitutions Range: No fixed maximum value (administration time-dependent) Interpretation: Higher scores indicate better attention and processing speed.
The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Neurocognitive Performance Evaluation: Executive and Attentive Functions - Stroop Color-Word Test (Short Version)
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Executive and attentional functioning assessed using the short version of the Stroop Color-Word Test. Participants are required to identify the color of printed stimuli while inhibiting automatic reading responses. Performance is evaluated based on completion time, number of correct responses, and/or errors made during the task, reflecting selective attention, cognitive flexibility, processing speed, and inhibitory control. Better performance is indicated by faster completion times and fewer errors.
The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Quality of Life (QoL)
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Quality of life will be evaluated through EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30). The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a 30-item instrument used to assess health-related quality of life in people with cancer. All scales and single items are linearly transformed to a 0-100 scale (Minimum: 0 and Maximum: 100).
The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Psychological status
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Psychological status will be evaluated through HADS questionnaire (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale consists of two subscales: anxiety (HADS-A) and depression (HADS-D). Each subscale ranges from 0 to 21, with higher scores indicating worse psychological outcomes (greater anxiety or depression symptoms).
The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Resilience
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Resilience will be evaluated through RS-14 questionnaire (Resilience scale-14 questionnaire). The Resilience Scale-14 produces a total score ranging from 14 to 98, with higher scores indicating a better outcome (greater resilience).
The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Treatment characteristics: Previous Central Nervous System Prophylaxis
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
History of Central Nervous System prophylaxis prior to CAR-T therapy, including intrathecal methotrexate and/or high-dose methotrexate, collected from medical records. Unit of Measure: Participants with previous CNS prophylaxis (%).
The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Treatment characteristics: Anthracycline Cumulative Dose
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Total cumulative dose of anthracycline chemotherapy received prior to CAR-T therapy, collected from medical records. Unit of Measure: Milligrams per square meter (mg/m²).
The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Treatment characteristics: Prior Radiotherapy Field
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Anatomical field of radiotherapy received prior to CAR-T therapy as recorded in medical records (e.g., mediastinal, cranial, total body irradiation, or other). Unit of Measure: Participants by radiotherapy field (%).
The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Treatment characteristics: Prior Radiotherapy Dose
大体时间：The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Total radiation dose delivered during previous radiotherapy treatments before CAR-T therapy, obtained from medical records. Unit of Measure: Gray (Gy).
The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fondazione Italiana Linfomi - ETS

合作者

Associazione Italiana contro Leucemie, Linfomi e Mieloma

调查人员

  • 首席研究员：Silvia Franceschetti、U.O.C. Ematologia Ospedale Civile di Legnano - ASST Ovest Milanese - Legnano

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年3月1日

研究完成 (估计的)

2028年3月1日

研究注册日期

首次提交

2026年6月11日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • FIL_LymDeCo

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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