Immunopathology of Autoimmune Hemolytic Anemia (NCT02158195) | Clinical Trial Compass
CompletedNot Applicable
Immunopathology of Autoimmune Hemolytic Anemia
France27 participantsStarted 2013-07-03
Plain-language summary
Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.
The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.
The role of treatments, such as steroids, will also be determined in patients with warm AIHA.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA)
* Secondary AHAI (infections, hematological diseases, systemic diseases)
* Naive of treatment for hemolytic anemia or in relapse
* Older than 16
* Able to understand written and spoken French
* who have provided written informed consent
* INCLUSION CRITERIA for CONTROLS
* Persons without auto-immune disease, cancer or active infection.
* Older than 16
* Able to understand written and spoken French
* who have provided written informed consent
Exclusion Criteria:
* Cold agglutinin disease
* Pregnancy
* Persons without national health insurance
Exclusion Criteria for Controls:
* Subjects treated with corticosteroids or immunosuppressants
* Pregnancy
* Persons without national health insurance
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+)
Timeframe: Change from baseline to 3 months
2
physiological parameter : percentage of inhibiting LT proliferation inhibition