Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406179
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-29
Brief Title:
Assesment the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomized Controlled Multicenter Trial to Sassess the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AI-CARE
Brief Summary:
The investigator hypothesizes that the combined use of 1 Donor-derived cell-free DNA dd-cfDNA in peripheral blood predicting anti-donor immunological activation or quiescence 2 interactive and actionable data analytics delivered at the bedside will promote safe clinical follow-up of kidney transplant patients with less need for invasive biopsy and less induced risk surveillance by allograft protocol biopsies to assess allograft rejection in clinically stable kidney transplant patients
In addition the evaluation of the transcriptional changes in tissue samples in selected patients using automated processing of digital slide images and intragraft gene expression profiles will provide a better diagnosis of the rejection mechanisms to provide the best therapeutic approach as compared to current clinical practice
We therefore propose a French multicenter prospective randomized trial comparing two strategies of follow-up in the first group a biopsy is performed at M3 M12 and for clinical indication whenever considered necessary by the clinician during the first 18 months of follow-up after transplant In the second group biopsies are guided by dd-cfDNA at the same timepoints
In addition the evaluation of the transcriptional changes in tissue samples in selected patients using automated processing of digital slide images and intragraft gene expression profiles will provide a better diagnosis of the rejection mechanisms to provide the best therapeutic approach as compared to current clinical practice
We therefore propose a French multicenter prospective randomized trial comparing two strategies of follow-up in the first group a biopsy is performed at M3 M12 and for clinical indication whenever considered necessary by the clinician during the first 18 months of follow-up after transplant In the second group biopsies are guided by dd-cfDNA at the same timepoints
Detailed Description:
The main objective of this study is to demonstrate the ability of dd-cfDNA levels in the blood combined with clinical data to decrease the number of allograft biopsies during the first 18 months after transplantation
500 new transplanted patients in 5 Frenchclinical transplant sites will be included in the prospective multicenter AI-CARE trial Recruitment of patients will start on the day of transplantation or 8 days before for transplantations with living donor and datasamples collected at 3 months and 12 months after transplantation and during visits for clinical indication within the first 18 months of follow-up Realization of all the acts for the research are representing the usual medical practice Standard Of Care SOC except one additional blood sample for dd-cfDNA analyses that will be collected and analyzed specifically for the research The paraffin-embedded core dedicated to SOC histology will be used for gene expression profiling and digital pathology imaging after SOC procedures
Using the newest information derived from dd-cfDNA analyses combined with clinical data dd-cfDNA will allow us to identify kidney transplant patients at low- and high-risk of rejection
using non-invasive dd-cfDNA levels combined with clinical data preventing unnecessary allograft biopsies which are invasive with and present a potential risk of complications for the patients and costly burden to the healthcare vasive with a potential risk of complications for the patients and costly to the healthcare system
500 new transplanted patients in 5 Frenchclinical transplant sites will be included in the prospective multicenter AI-CARE trial Recruitment of patients will start on the day of transplantation or 8 days before for transplantations with living donor and datasamples collected at 3 months and 12 months after transplantation and during visits for clinical indication within the first 18 months of follow-up Realization of all the acts for the research are representing the usual medical practice Standard Of Care SOC except one additional blood sample for dd-cfDNA analyses that will be collected and analyzed specifically for the research The paraffin-embedded core dedicated to SOC histology will be used for gene expression profiling and digital pathology imaging after SOC procedures
Using the newest information derived from dd-cfDNA analyses combined with clinical data dd-cfDNA will allow us to identify kidney transplant patients at low- and high-risk of rejection
using non-invasive dd-cfDNA levels combined with clinical data preventing unnecessary allograft biopsies which are invasive with and present a potential risk of complications for the patients and costly burden to the healthcare vasive with a potential risk of complications for the patients and costly to the healthcare system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None