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Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia (BIOCAI)
| Condition or disease | Intervention/treatment |
|---|---|
| Immune Thrombocytopenia Autoimmune Hemolytic Anemia Autoimmune Neutropenia | Biological: blood sample Biological: urine sample |
Our department follows about 350 patients with immune thrombocytopenia (ITP), 50 with autoimmune hemolytic anemia (AHA), and about thirty patients for autoimmune neutropenia and erythroblastopenia. The number of new patients per year is about 50. The investigators are working since several years on different research topics concerning ITP and AHA.
In the field of ITP, the investigators are working on abnormalities of megakaryopoiesis present in a particular subgroup of patients. The investigators seek to identify the molecular mechanisms underlying this platelet-forming disorder. This research is done within the INSERM U1034 unit of the University of Bordeaux.
In AHA, The investigators are working on the role of regulatory CD8+ T lymphocytes and the interest of low doses of Interleukin-2 in their treatment. This part is carried out within the CNRS unit UMR 5164 ImmunoConcept. The biological collection the investigators wish to create will be available for basic research projects and may be available to the pharmaceutical industry as part of the development of new molecules.
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia |
| Actual Study Start Date : | February 2, 2019 |
| Estimated Primary Completion Date : | February 2022 |
| Estimated Study Completion Date : | February 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Autoimmune Cytopenia |
Biological: blood sample
45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Biological: urine sample 12 ml
|
- Number of patients with autoimmune cytopenia at diagnosis, or followed but not treated with a biological library (serum, plasma, DNA) [ Time Frame: At baseline (Day 0) ]
Biospecimen Retention: Samples With DNA
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients over 16 years old.
- Patients with autoimmune cytopenia according to the definitions reported in the latest update of the French National Care Protocol (PNDS 2017).
- Affiliated person or beneficiary of a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Exclusion Criteria:
- Positivity for HIV, Hepatitis C or B virus.
- Pregnant or lactating woman.
- Patient undergoing treatment for autoimmune cytopenia
| Contact: Jean-François VIALLARD, Prof | 05.57.65.64.83 ext +33 | jean-françois.viallard@chu-bordeaux.fr | |
| Contact: Isabelle RAYMOND, Pharm | isabelle.raymond@chu-bordeaux.fr |
| France | |
| CHU de Bordeaux - service de médecine interne | Recruiting |
| Pessac, France | |
| Contact: Jean-François VIALLARD, Prof 05.57.65.64.83 ext +33 jean-françois.viallard@chu-bordeaux.fr | |
| Contact: Isabelle RAYMOND, Pharm isabelle.raymond@chu-bordeaux.fr | |
| Principal Investigator: Jean-François VIALLARD, Prof | |
| Sub-Investigator: Estibaliz LAZARO, Prof | |
| Sub-Investigator: Jean-Luc PELLEGRIN, Prof | |
| Sub-Investigator: Carine GREIB, MD | |
| Sub-Investigator: Irene MACHELARD, MD | |
| Sub-Investigator: Etienne RIVIERE, MD | |
| Principal Investigator: | Jean-François VIALLARD, Prof | CHU Bordeaux |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 17, 2019 | ||||||||
| First Posted Date | July 2, 2019 | ||||||||
| Last Update Posted Date | December 23, 2020 | ||||||||
| Actual Study Start Date | February 2, 2019 | ||||||||
| Estimated Primary Completion Date | February 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Number of patients with autoimmune cytopenia at diagnosis, or followed but not treated with a biological library (serum, plasma, DNA) [ Time Frame: At baseline (Day 0) ] | ||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia | ||||||||
| Official Title | Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia | ||||||||
| Brief Summary | The Internal Medicine Department of Haut-Lévêque Hospital (Pr E LAZARO, Pr JL PELLEGRIN, Pr JF VIALLARD) was accredited in 2017 by the Ministry of Health as a Constitutive Reference Center for Autoimmune Cytopenia. The investigators wish to launch new research projects in autoimmune cytopenia and propose a translational and fundamental research based on collaboration between the clinical department, the biological resource center and the CNRS and INSERM research units ("Bedside to the Bench Strategy"). Thus, in the perspective of future research work, it seems imperative to set up a biological bank for the patients followed in our Reference Center. | ||||||||
| Detailed Description |
Our department follows about 350 patients with immune thrombocytopenia (ITP), 50 with autoimmune hemolytic anemia (AHA), and about thirty patients for autoimmune neutropenia and erythroblastopenia. The number of new patients per year is about 50. The investigators are working since several years on different research topics concerning ITP and AHA. In the field of ITP, the investigators are working on abnormalities of megakaryopoiesis present in a particular subgroup of patients. The investigators seek to identify the molecular mechanisms underlying this platelet-forming disorder. This research is done within the INSERM U1034 unit of the University of Bordeaux. In AHA, The investigators are working on the role of regulatory CD8+ T lymphocytes and the interest of low doses of Interleukin-2 in their treatment. This part is carried out within the CNRS unit UMR 5164 ImmunoConcept. The biological collection the investigators wish to create will be available for basic research projects and may be available to the pharmaceutical industry as part of the development of new molecules. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation and urine sample
|
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients with autoimmune cytopenia according to the definitions reported in the latest update of the French National Care Protocol (PNDS 2017). | ||||||||
| Condition |
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| Intervention |
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| Study Groups/Cohorts | Autoimmune Cytopenia
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | February 2022 | ||||||||
| Estimated Primary Completion Date | February 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04005638 | ||||||||
| Other Study ID Numbers | CHUBX 2018/13 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Hospital, Bordeaux | ||||||||
| Study Sponsor | University Hospital, Bordeaux | ||||||||
| Collaborators | Ministry for Health and Solidarity, France | ||||||||
| Investigators |
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| PRS Account | University Hospital, Bordeaux | ||||||||
| Verification Date | December 2020 | ||||||||
