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T Cell Profiling in Patients With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04789551
Recruitment Status : Not yet recruiting
First Posted : March 9, 2021
Last Update Posted : February 16, 2023
Sponsor:
Information provided by (Responsible Party):
Lifei Hou, Boston Children's Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The goal of this research study is to to learn more about the body's immune response in patients with multiple sclerosis (MS). In MS, the body's immune cells mistakenly attack an important part of the nerves of the brain and spinal cord. The immune cells responsible for attacking the nerves in MS patients is primarily the T cells. A marker was recently discovered that might specifically identify these damaging T cells from all other T cells in the body. Understanding which T cells cause the damage in MS patients and understanding more about these specific T cells may help doctors better understand how MS occurs and could possibly prevent MS in the future.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Blood Sample

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: T Cell Profiling in Patients With Multiple Sclerosis
Estimated Study Start Date : June 1, 2023
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Multiple Sclerosis Stable Conditions
Multiple sclerosis patients presenting for a routine clinic visit.
 Other: Blood Sample
a blood sample will be collected
Multiple Sclerosis Acute Flare Up
Multiple sclerosis patients admitted to the hospital with acute symptoms.
 Other: Blood Sample
a blood sample will be collected
Control patients
Patients without any immunological diseases who present for elective surgery.
 Other: Blood Sample
a blood sample will be collected


Outcome Measures
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Primary Outcome Measures :
  1. T cell populations [ Time Frame: up to one week ]
    compare T cell populations between patients with Multiple Sclerosis and healthy controls


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Multiple Sclerosis who present to Boston Children's Hospital will be enrolled. A group of healthy control patients who present for elective surgery at Boston Children's Hospital will also be enrolled.
Criteria

MS Group Inclusion criteria

-diagnosis of multiple sclerosis and present to the neurology clinic for a regular checkup or are admitted to the inpatient floor with acute symptoms.

Exclusion criteria

  • Have an active infection
  • Take T cell modulating drugs

Control Group Inclusion criteria -scheduled for elective surgery

  • without any immunological diseases. Exclusion criteria
  • Have an active infection.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04789551


Contacts
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Contact: Lifei Hou, PhD 617-713-8154 lifei.hou@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hopsital
Boston, Massachusetts, United States, 02115
Contact: Lifei Hou, PhD       lifei.hou@childrens.harvard.edu   
Contact: Koichi Yuki, MD    617-355-6225    koichi.yuki@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children's Hospital
More Information
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Responsible Party: Lifei Hou, Principal Investigator, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04789551    
Other Study ID Numbers: IRB-P00037843
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: February 16, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases