- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04231253
MUltiple Sclerosis : T Cell / B Cell Exploration (MUST-BE)
T Cell/B Cell Collaboration in Multiple Sclerosis: Exploring an Intimate Relationship
연구 개요
상태
정황
상세 설명
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the Central Nervous System (CNS) affecting mostly young adults between 20 and 40 years of age. This disease is the leading cause of non-traumatic disability in young adults.
MS has long been considered a predominantly T-cell mediated disease. However, the remarkable efficacy of anti-CD20 monoclonal antibodies in this disease has demonstrated the major role of B-cell in the pathophysiology of this disease.
The B-cell have many functions: these cells are indeed able to secrete cytokines (pro and anti inflammatory), to present antigens to T lymphocytes, but also to differentiate into plasmocytic cells and thus to secrete immunoglobulins. Several studies have shown that B-cell in patients with MS secrete significantly more pro-inflammatory cytokines (GM-CSF, IL-6, TNFα). In addition, infiltrates and tertiary lymphoid structures have been found in the meninges of patients with MS, particularly in progressive forms of the disease. It seems clear to this day that these cells are strongly involved in the development of MS. Despite the many advances made recently in understanding the role of B-cell in the pathophysiology of MS, the precise involvement of plasma cells and their functions at different stages of the disease remains unclear.
Folluclar helper T cells (TFH) play a crucial role in lymphocyte B differentiation. These cells are located within the germinal centers in the secondary lymphoid organs, and their memory compartment also circulates in the blood. Several circulating TFH subpopulations have recently been defined, with different "helping" capacities.
This study, an ancillary to ABCD-SEP (NCT03744351), will be interested in more precisely characterizing circulating and infiltrating TH cells in Multiple Sclerosis whether at the transcriptomic level or at the functional level.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Rennes, 프랑스, 35033
- Rennes University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
The population concerned is the same as the one participating in the ABCD-SEP study.
These patients gave their consent for the remaining biological samples to be used for ulterior research
설명
Inclusion Criteria:
Regarding MS patients (remitting or progressive untreated):
- Adult (age greater than or equal to 18 years) of both sexes;
- MS fulfilling the criteria of McDonald 2017;
- Remittent or progressive form;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
Regarding Clinically Isolated Syndrome:
- Adult (age greater than or equal to 18 years) of both sexes;
- Clinically isolated syndrome suggestive of MS (at least two typical lesions in two different locations);
- Patient receiving a Lumbar Puncture (PL) for diagnostic purposes;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
Regarding non-MS patients with neurological inflammatory disease:
- Adult (age greater than or equal to 18 years) of both sexes;
- Patient with non-MS neurological inflammatory disease (examples: meningitis, neurolupus, neurosarcoidosis...);
- Patients with PL for diagnostic or surveillance purposes;
- No immunomodulatory or immunosuppressive therapy for at least 3 months;
- Free, informed and written consent signed by the patient.
Regarding healthy volunteers:
- Adult (age greater than or equal to 18 years) of both sexes;
- Free, informed and written consent signed by the volunteer.
Exclusion Criteria:
Regarding all patients:
- Pregnancy;
- Breastfeeding;
- Treatment with corticotherapy in the last month;
- Patient not affiliated to health insurance;
- Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
Regarding healthy volunteers:
- Pregnancy;
- Breastfeeding;
- Not affiliated to social security;
- Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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To compare the transcriptome profile of infiltrating TFH cells from CIS patients to non-MS patients with neurological inflammatory diseases
기간: At inclusion
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Comparison of each gene expression of infiltrating TFH cells from CIS patients to those of non-MS patients with neurological inflammatory diseases by RNAsequencing
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At inclusion
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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To compare the transcriptome profile of infiltrating TFH cells from CIS patients to healthy volunteers.
기간: At inclusion
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Comparison of each gene expression of infiltrating TFH cells from CIS patients to those of healthy volunteers (HV) by RNAsequencing
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At inclusion
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To compare the B cell differentiation helping abilities of TFH cells from MS patients to those of HV
기간: At inclusion
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Analysis of B cell phenotype after 7 days of in vitro coculture assays and comparison of the frequencies between MS patients and HV
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At inclusion
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To compare the migration abilities of TFH cells from MS patients to those of HV
기간: At inclusion
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Analysis of the rate, number and phenotype of migrating TFH cells after 12 to 24 hours using an in vitro model of Blood Brain Barrier in MS patients compared to HV
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At inclusion
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공동 작업자 및 조사자
수사관
- 수석 연구원: Laure Michel, Rennes University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 35RC19_8871_MUST-BE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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다발성 경화증에 대한 임상 시험
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University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스