Immunological Aspect of Thrombotic Thrombocytopenic Purpura (TTP)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen
About this trial
The general objective of the proposed project is to characterise phenotypically and functionally ADAMTS13-specific memory B lymphocytes and autoreactive T lymphocytes, in particular follicular helper T lymphocytes, in the acute phase of the disease, but also during its progression after treatment. The aim is to highlight their contribution to the initial pathogenic process, their evolution under treatment, and also their involvement in patients who are refractory to immunosuppressive therapies and during relapses. The aim of this project is to identify early phenotypic or functional parameters that are predictive of relapse and that can be used for personalised optimisation of treatment to maintain remission.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age over 18
patients with TTP at any stage of diagnosis (acute phase, lasting remission or not, relapse)
patients undergoing internal medicine at Rouen University Hospital
people who have read and understood the information letter
Disqualifiers
None
Trial population
patients with thrombotic thrombocytopenic purpura, whatever the stage of diagnosis (acute phase, lasting remission or not, relapse)
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
44 Participants
are grouped into 4 trial groupsGroup A: Group 1: patients in the acute phase of TTP
Group B: Groupe 2 : patient in durable remission with ADAMTS13 activity > 10%.
Group C: Groupe 3 : patient in remission with ADAMTS13 activity < 10%.
Group D: Group 4: relapsing patients
Trial outcomes
Primary outcomes
1
Identifying the presence of circulating autoreactive T lymphocytes
Identifying the presence of circulating autoreactive T lymphocytes in patients with TTP using the ELISPOT technique (Demonstration of spots indicating the presence of gamma interferon-producing T lymphocytes)
Time frame
At enrollment visit, Month 3, Month 6 and month 122
Identify the presence of circulating autoreactive B lymphocytes
Identifying the presence of circulating autoreactive B lymphocytes in patients with TTP using the ELISPOT technique (Demonstration of IL-21 spots and specific B lymphocytes producing anti-ADAMTS13 antibodies in response to the ADAMTS13 antigen)
Time frame
At enrollment visit, Month 3, Month 6 and month 12Secondary outcomes
1
Study quantitative variations in circulating autoreactive T lymphocytes
Study quantitative variations in circulating autoreactive T lymphocytes in patients with TTP (Definition Number of T lymphocytes producing gamma interferon and IL-21 in response to ADAMTS13 antigen as determined by ELISPOT)
Time frame
At enrollment visit, Month 3, Month 6 and month 122
Study quantitative variations in circulating autoreactive B lymphocytes
Study quantitative variations in circulating autoreactive B lymphocytes in patients with TTP (define the number of specific B lymphocytes producing anti-ADAMTS13 antibodies as determined by ELISPOT)
Time frame
At enrollment visit, Month 3, Month 6 and month 123
Determine the phenotypic characteristics of circulating autoreactive T lymphocytes
Determine the phenotypic characteristics of circulating autoreactive T lymphocytes in patients with TTP (Determination of the number of effector and memory T lymphocyte subpopulations specific for ADAMTS13 by ELISPOT)
Time frame
At enrollment visit, Month 3, Month 6 and month 124
Determine the phenotypic characteristics of circulating autoreactive B lymphocytes
Determine the phenotypic characteristics of circulating autoreactive B lymphocytes in patients with TTP (Assessment of the number of mature B lymphocyte subpopulations that are naive or memory ADAMTS13 specific)
Time frame
At enrollment visit, Month 3, Month 6 and month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov