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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

観察的

入学 (推定)

100

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Iolanda Uffici Studi FIL
  • 電話番号：+390131033153
  • メール：startup@filinf.it

研究場所

  • イタリア
      • Ancona、イタリア
      • Aviano、イタリア
        • Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
        • コンタクト：
      • Bari、イタリア
        • U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
        • コンタクト：
      • Legnano、イタリア
        • U.O.C. Ematologia Ospedale Civile di Legnano - ASST Ovest Milanese
        • コンタクト：
      • Milan、イタリア
        • SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
        • コンタクト：
      • Milan、イタリア
        • Ematologia - Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda
        • コンタクト：
      • Palermo、イタリア
        • Ematologia - AOU Policlinico Giaccone
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Self-assessed neurocognitive performance
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Fondazione Italiana Linfomi - ETS

協力者

Associazione Italiana contro Leucemie, Linfomi e Mieloma

捜査官

  • 主任研究者：Silvia Franceschetti、U.O.C. Ematologia Ospedale Civile di Legnano - ASST Ovest Milanese - Legnano

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年3月1日

研究の完了 (推定)

2028年3月1日

試験登録日

最初に提出

2026年6月11日

QC基準を満たした最初の提出物

2026年6月11日

最初の投稿 (実際)

2026年6月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月22日

QC基準を満たした最後の更新が送信されました

2026年6月17日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • FIL_LymDeCo

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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