跳至主要内容
临床试验/NCT07268833
NCT07268833招募中不适用

Translating Single-cell Vulnerability Into Novel ALS Biomarkers and Therapeutic Targets: Towards a Liquid Nerve Biopsy

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年10月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
4
主要终点
Diagnostic ALS biomarkers

研究概览

简要总结

The progress of ALS research and clinical practice is hampered by lack of effective biomarkers to monitor disease onset and progression. In response to this urgent need, we will integrate single-cell system biology approaches, histopathological and clinical data from precious human nerve biopsies collected from living ALS patients during the diagnostic workup and findings from innovative preclinical mouse models to unmask cell-specific molecular alterations that arise in the PNS tissue during the course of ALS pathology. This information will be used to select protein biomarkers of dysfunctional states associated with pre-manifest or early symptomatic stages of the disease, which will be further screened and validated in patient biofluids. Altogether, this project will lead to the discovery of novel, reliable and specific ALS biomarkers while providing insights into ALS mechanisms by leveraging an original "PNS perspective" on disease pathogenesis.

详细描述

The absence of specific biomarkers poses a significant impediment to the advancement of new treatments for amyotrophic lateral sclerosis (ALS), a severe and rapidly fatal neurodegenerative disease with no cure to date, defined by degeneration of motor neurons. Early pathological events, such as the selective damage of motor axons and the loss of neuromuscular connections, precede complete neurodegeneration and the manifestation of clinical symptoms. Therefore, we argue that understanding disease-related changes occurring in peripheral nerves is crucial for defining the underlying pathogenetic mechanisms. Preliminary data from our research team suggest that phosphorylated TDP-43, the pathological hallmark of ALS, forms aggregates in motor axons and Schwann cells of living ALS patients before the onset of axonal degeneration. However, peripheral nerves constitute complex multicellular tissues, and the specific contributions of individual cellular components to ALS pathology remain poorly understood. The overarching concept of this proposal is that distinct cell types within the nerve tissue (e.g., Schwann cells, endothelial cells, fibroblasts, macrophages) function as exquisite early detectors of motor neuron damage and initiate secondary responses that amplify neuropathology. These studies will steer the analysis of minimally invasive skin biopsies to uncover deregulated PNS signatures in ALS patients. Finally, candidate molecular targets reflecting cell-type-specific deregulation in the diseased nerve microenvironment will be screened in the biofluids of ALS patients and at-risk individuals from genetic ALS families, enabling the discovery of novel diagnostic and prognostic biomarkers. The integrative approach proposed in this study will elucidate the pathogenic mechanisms of ALS and establish a roadmap towards identifying potential therapeutic targets.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic ALS biomarkers

时间窗: 20 months

Throughout the study, we will validate, starting from transcriptomics data, novel diagnostic biomarker for an early diagnosis of ALS

次要结局

  • Prognostic biomarkers(24 months)
  • Therapeutic targets(24 months)

研究者

发起方
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验

尚未招募
1 期
CellThRPE1
2024-517546-33-00St Erik Eye Hospital15
进行中(未招募)
1 期
Personalized Antisense Oligonucleotide for A Single Participant With ATN1 Gene Mutation
NCT07084311n-Lorem Foundation1
进行中(未招募)
1 期
A Study to Assess the Safety, Pharmacokinetics (how the body affects the drug), and Efficacy (how well the drug works) of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients from Birth to < 1 Year with Influenza-Like SymptomsInfluenza
EUCTR2018-002154-70-BGF. Hoffmann-La Roche Ltd30
进行中(未招募)
1 期
A Study to Assess the Safety, Pharmacokinetics (how the body affects the drug), and Efficacy (how well the drug works) of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients from Birth to < 1 Year with Influenza-Like SymptomsMedDRA version: 20.0Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 100000004862MedDRA version: 20.1Level: LLTClassification code 10022003Term: Influenza B virus infectionSystem Organ Class: 100000004862MedDRA version: 20.1Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 100000004862MedDRA version: 20.0Level: LLTClassification code 10016790Term: FluSystem Organ Class: 100000004862Influenza
EUCTR2018-002154-70-PLF. Hoffmann-La Roche Ltd30
进行中(未招募)
1 期
A Study to Assess the Safety, Pharmacokinetics (how the body affects the drug), and Efficacy (how well the drug works) of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients from Birth to < 1 Year with Influenza-Like SymptomsMedDRA version: 20.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862MedDRA version: 20.1 Level: LLT Classification code 10022003 Term: Influenza B virus infection System Organ Class: 100000004862MedDRA version: 20.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862MedDRA version: 20.0 Level: LLT Classification code 10016790 Term: Flu System Organ Class: 100000004862Influenza
EUCTR2018-002154-70-ESRoche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann30