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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: CHU Nantes département promotion
- Telefonnummer: +33 253482835
- E-Mail: bp-prom-regl@chu-nantes.fr
Studienorte
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Nantes, Frankreich, 44093
- Nantes Universitary hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: CASE_ONLY
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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." |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Perceived stress score related to the 1-year surveillance biopsy
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- RC26_0150
- 2026-A01329-42 (Andere Kennung: ANSM)
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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