Observing patients with thrombotic microangiopathy linked to Mitomycin C treatment
Retrospective Study of Patients With Thrombotic Microangiopathy Associated With Mitomycin C, Treated or Not With Eculizumab: Clinical Characteristics and and Outcome of These Patients
This study looks at adults who developed a serious blood condition after receiving Mitomycin C chemotherapy to see how common it is and what happens to them, with or without a specific treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | Eculizumab, chemotherapy |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06098378 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients who have developed thrombotic microangiopathy (TMA) as a complication of Mitomycin C chemotherapy. It aims to gather data on the incidence and outcomes of TMA in these patients, regardless of whether they have received treatment with Eculizumab, a monoclonal antibody that may improve prognosis. The study will include adult patients who have received Mitomycin C between 1990 and 2023 and have shown signs of TMA. The research will analyze clinical data to better understand the condition and its treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received Mitomycin C and developed thrombotic microangiopathy.
Not a fit: Patients who have not received Mitomycin C or do not exhibit symptoms of thrombotic microangiopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients suffering from Mitomycin C-induced thrombotic microangiopathy.
How similar studies have performed: While there is existing research on thrombotic microangiopathies, this specific observational approach focusing on Mitomycin C-induced cases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (\>=18 years) * Having received treatment with mitomycin C (regardless of the method of administration and indication) between 01/01/1990 and 12/31/2023 * and having developed a picture of thrombotic microangiopathy attributed to mitomycin C: * biological: defined as: thrombocytopenia \<150G/L and mechanical hemolytic anemia (at least 3 out of 4 criteria: hemoglobin \< 12g/dL, presence of schistocytes in blood smear, LDH \> 1N, collapsed haptoglobin (\< lower limit of the limit of laboratory normal) * or renal: pathological diagnosis of thrombotic microangiopathy on renal biopsy * having received or not treatment for the episode of microangiopathy, including or not complement inhibitors (Eculizumab). * Subject not opposing, after information, the reuse of their data for the purposes of this research Exclusion Criteria: * Subject having expressed opposition to participating in the study * Test for positive Shiga toxin * ADAMST13 activity \<10% * Thrombotic microangiopathy attributed to metastatic cancer (infiltration of bone marrow or circulating erythroblasts) * Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.) * Subject under judicial protection * Subject under guardianship or curatorship
Where this trial is running
Strasbourg
- Service de Néphrologie, Dialyse et Transplantation - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Anna DUVAL, MD
- Email: anna.duval@chru-strasbourg.fr
- Phone: 33 3 69 55 05 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.