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

2026년 6월 11일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

100

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Iolanda Uffici Studi FIL
  • 전화번호: +390131033153
  • 이메일: startup@filinf.it

연구 장소

  • 이탈리아
      • Ancona, 이탈리아
      • Aviano, 이탈리아
        • Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
        • 연락하다:
      • Bari, 이탈리아
        • U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
        • 연락하다:
      • Legnano, 이탈리아
      • Milan, 이탈리아
        • SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
        • 연락하다:
      • Milan, 이탈리아
        • Ematologia - Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda
        • 연락하다:
      • Palermo, 이탈리아
        • Ematologia - AOU Policlinico Giaccone
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Self-assessed neurocognitive performance
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Neurocognitive performance evaluation: Cognitive Status - Mini-Mental State Examination (MMSE)
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Neurocognitive performance evaluation: Language - Verbal Fluency Test (Phonemic and semanthic)
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Neurocognitive performance evaluation: Language - Naming of colored Photographs
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Neurocognitive performance evaluation: Verbal Memory - Digit Span Test (Forward, Backward)
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Neurocognitive performance evaluation: Verbal Memory - Rey Auditory Verbal Learning Test (Word List 3 Recall)
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Neurocognitive performance evaluation: Visual-spatial memory/praxic-constructive functions - Corsi Span Test (Forward, Backward)
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Neurocognitive performance evaluation: Visual-spatial memory/praxic-constructive functions - Rey-Osterrieth Complex Figure Test (ROCF)
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Neurocognitive performance status: Executive and attentive functions - Trail Making Test (TMT) Part A and B
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Neurocognitive performance evaluation: Executive and attentive functions - Symbol Digit Modalities Test (SDTM) - Oral Version
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Neurocognitive Performance Evaluation: Executive and Attentive Functions - Stroop Color-Word Test (Short Version)
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Quality of Life (QoL)
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Psychological status
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Resilience
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Treatment characteristics: Previous Central Nervous System Prophylaxis
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Treatment characteristics: Anthracycline Cumulative Dose
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Treatment characteristics: Prior Radiotherapy Field
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.
Treatment characteristics: Prior Radiotherapy Dose
기간: The endpoint will be evaluated only once after screening and signing of informed consent form.
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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fondazione Italiana Linfomi - ETS

협력자

Associazione Italiana contro Leucemie, Linfomi e Mieloma

수사관

  • 수석 연구원: Silvia Franceschetti, U.O.C. Ematologia Ospedale Civile di Legnano - ASST Ovest Milanese - Legnano

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2028년 3월 1일

연구 완료 (추정된)

2028년 3월 1일

연구 등록 날짜

최초 제출

2026년 6월 11일

QC 기준을 충족하는 최초 제출

2026년 6월 11일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 11일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • FIL_LymDeCo

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

전형적인 Hodgkin 림프종에 대한 임상 시험

anthracycline containing regimen에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in El Salvador

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다