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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: CHU Nantes département promotion
- Telefonnummer: +33 253482835
- E-post: bp-prom-regl@chu-nantes.fr
Studiesteder
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Nantes, Frankrike, 44093
- Nantes Universitary hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_ONLY
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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." |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Perceived stress score related to the 1-year surveillance biopsy
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- RC26_0150
- 2026-A01329-42 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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