Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection (ABAT)
ABAT - Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
There is currently no consensus recommendation regarding the routine use of surveillance kidney allograft biopsies during the first year after transplantation. As a result, the decision to perform surveillance biopsies remains center-dependent, and their long-term clinical benefit has not been conclusively demonstrated.
Although surveillance biopsy is considered the gold standard for detecting subclinical rejection, it is an invasive and costly procedure that carries a risk of complications. Furthermore, approximately 30-35% of surveillance biopsies reveal normal or near-normal histology, highlighting the need for strategies that can safely reduce unnecessary biopsies and improve patient comfort while optimizing healthcare resource utilization.
At Nantes University Hospital, three blood and urinary biomarkers predictive of the absence of rejection are routinely used to assess the relevance of performing a surveillance biopsy. The objective of this observational study is to evaluate patients' perceived stress related to the 1-year surveillance biopsy according to whether the procedure is maintained or canceled based on the results of these non-invasive biomarkers used in standard clinical practice.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: CHU Nantes département promotion
- Telefoonnummer: +33 253482835
- E-mail: bp-prom-regl@chu-nantes.fr
Studie Locaties
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Nantes, Frankrijk, 44093
- Nantes Universitary hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
The study population will consist of a prospective cohort of kidney transplant recipients followed at Nantes University Hospital over a 12-month inclusion period.
The study will compare perceived stress related to the 1-year surveillance biopsy according to whether the biopsy was performed or waived based on the results of the non-invasive biomarkers used in routine clinical practice.
Beschrijving
Inclusion Criteria:
- Adult patients aged 18 years or older;
- Recipients of a kidney transplant from a living donor, a donor after brain death, or a donor after circulatory death;
- Patients who have provided written informed consent to participate in the ABAT study.
Exclusion Criteria:
- Pregnant or breastfeeding women;
- Patients under legal protection measures (including guardianship or curatorship);
- Patients who have undergone more than two kidney transplantations;
- Patients who have received a combined transplant or a previous transplant of another organ.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_ONLY
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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ABAT Study population
The study population will consist of a prospective cohort of kidney transplant followed at Nantes University Hospital over a 12-month inclusion period. |
Collection of blood and urine samples at 3 months for the assessment of blood and urinary biomarkers (these samples will not be used to guide the decision to perform or cancel the surveillance biopsy. They will be stored in the study biocollection for future ancillary biomarker analyses): One PAXgene® tube (SCR score): 2.5 mL of peripheral venous blood. One Streck® Cell-Free DNA BCT tube (dd-cfDNA): 10 mL of peripheral venous blood. One sterile urine collection tube (CXCL9/CXCL10 assay): 6 mL of fresh urine. To assess perceived stress related to the surveillance biopsy procedure, whether guided by the biomarker-based decision algorithm or not, participants will complete a self-administered questionnaire using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 corresponds to "no stress" and 10 to "the highest level of stress imaginable." |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Perceived stress score related to the 1-year surveillance biopsy
Tijdsspanne: 12 months
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score ranging from 0 to 10, with higher scores indicating high stress level. |
12 months
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- RC26_0150
- 2026-A01329-42 (Andere identificatie: ANSM)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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