Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation (ORLY-Est)
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| ClinicalTrials.gov Identifier: NCT02843867 |
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Recruitment Status :
Recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
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| Tracking Information | |||||||||
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| First Submitted Date | July 8, 2016 | ||||||||
| First Posted Date | July 26, 2016 | ||||||||
| Last Update Posted Date | July 26, 2016 | ||||||||
| Study Start Date | November 2008 | ||||||||
| Estimated Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Percentage of regulatory T cells related to atherosclerotic complications events. [ Time Frame: 5 or 10 years ] | ||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation | ||||||||
| Official Title | Influence de l'ORientation de la réponse LYmphocytaire Sur la Survenue de Complications athéromateuses après Transplantation rénale (étude ORLY-EST 2) | ||||||||
| Brief Summary | The incidence of atherosclerotic complications is increased after kidney transplantation. Traditional risk factors do not fully explain this increased risk. Atherosclerosis is an inflammatory disease in which all players in the immune response are involved. The impact of these immune responses is not well known in immunocompromised patients, particularly among organ transplant. Nevertheless, the work of our group suggest that innate and acquired responses through different mechanisms influencing the evolution of atheromatous disease after transplantation. The investigators therefore propose to study the impact of the expansion of regulatory T cells on the risk of atherosclerotic complications after transplantation. Since November 2008, the investigators began a multicenter, prospective study whose purpose is to study in detail the immunological mechanisms of atherosclerosis after transplantation via immunomonitoring cohort of renal transplant patients in the Grand East Interregion. It was planned to include 500 patients and to date a little more than half have been included. After completion of the blood test, the tubes are routed over the Biomonitoring Platform (CIC-BT 506 Besançon) and the samples are stored in CRB Dijon. The atherosclerotic events are recorded prospectively. The investigators hope to implement as part of ORLY IS, a second study to determine the impact of an expansion of regulatory T cells on the risk of atherosclerotic events. Our hypothesis is that a cell rate regulatory T below the median results in an increase of 5% of atherosclerotic complications. |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Serum Peripheral Blood Mononuclear Cells
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| Sampling Method | Probability Sample | ||||||||
| Study Population | The study population corresponds to 1000 patients receiving a renal transplant in Hospital of Besançon, Dijon, Nancy, Reims, Clermont-Ferrand, Strasbourg et Kremlin-Bicêtre. | ||||||||
| Condition | Disorder Related to Renal Transplantation | ||||||||
| Intervention | Other: blood sample
36 ml of blood sample at D0 and 1 year after transplantation
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * |
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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 |
1000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 2026 | ||||||||
| Estimated Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
This study is strictly non-interventional, participation in another study is not a cons-indication to the inclusion in this study and no exclusion period is required for inclusion in another study after inclusion in this study (Art L. 1121-12 (loi n°2004-806 du 9 Août 2004). |
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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 | NCT02843867 | ||||||||
| Other Study ID Numbers | R/2011/44 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement |
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| Responsible Party | Centre Hospitalier Universitaire de Besancon | ||||||||
| Study Sponsor | Centre Hospitalier Universitaire de Besancon | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Centre Hospitalier Universitaire de Besancon | ||||||||
| Verification Date | July 2016 | ||||||||