Molecular Transcriptomics in Diagnosing Pediatric Kidney Transplant Rejection: the PANDA-Kids-ATLAS Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Kidney Rejection Transplant. Basic parameters: 0 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Precision Allograft Rejection Using Novel Diagnostic Approaches in Kidney Transplantation - Allograft Transcriptomics Landscape Analysis Using Sequencing (the PANDA-Kids-ATLAS Study)
Overview
Children with kidney failure have markedly increased mortality and face repeated transplantation over their lifetime due to limited allograft half-life (12-15 years). Current biopsy-based diagnoses of rejection (using Banff 2022 criteria) suffer from variability and limited sensitivity. PANDA-Kids-ATLAS will analyze up to 600 pediatric FFPE kidney biopsies across multiple centres using the Banff Human Organ Transplant (B-HOT) NanoString panel to develop and validate molecular classifiers of AMR, TCMR and related phenotypes. A secure REDCap database will integrate molecular, pathological and clinical data, aiming to improve early detection, personalize therapy, and enhance long-term graft survival and patient quality of life.
Detailed description
The study builds a deeply phenotyped international cohort of pediatric transplant patients (\<21 years) with both retrospective (2014-present) and prospective (through Dec 2027) biopsy sampling. Four diagnostic "baskets" (classical AMR/TCMR; probable ABMR/MVI; other injury; normal) will each contribute equal numbers of cases for classifier validation (Part A) and real-world prevalence samples for outcome association (Part B). FFPE blocks will be centrally reviewed via Banff 2022 automated and expert pathologist interpretation, then processed by NanoString nCounter® using the 770-gene B-HOT panel. Stratified random sampling, robust QC, and integration with clinical/immunological parameters in REDCap will underpin molecular classifier development and validation. Follow-up includes clinical outcomes and graft function monitoring.
Primary outcome measures
- Identification of Molecular Classifiers for Kidney Allograft Rejection Using Banff Human Organ Transplant (B-HOT) Gene Panel via NanoString nCounter® [Time frame: 3 years]
Secondary outcome measures (2)
- Integration of Molecular Classifiers with Clinical Parameters into an Archetype-based Diagnostic System for Kidney Allograft Rejection [Time frame: 3 years]
- Integration of Molecular Classifiers with Biological and Immunological Parameters into an Archetype-based Diagnostic System for Kidney Allograft Rejection [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Age ≤ 21 years
- Single kidney transplant recipients (deceased or living donor)
- Written informed consent from patients/guardians
Exclusion criteria
- Multi-organ transplantation history
- Biopsies with insufficient tissue
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Paris Institute for Transplantation and Organ Regeneration (PITOR) — Paris
Publications
- Sablik M, Sannier A, Raynaud M, Goutaudier V, Divard G, Astor BC, Weng P, Smith J, Garro R, Warady BA, Zahr RS, Twombley K, Dharnidharka VR, Dandamudi RS, Fila M, Huang E, Sellier-Leclerc AL, Tonshoff B, Rabant M, Verine J, Del Bello A, Berney T, Boyer O, Catar RA, Danger R, Giral M, Yoo D, Girardin FR, Alsadi A, Gourraud PA, Morelon E, Le Quintrec M, Try M, Villard J, Zhong W, Bestard O, Budde K, PMID 39450752
- Halloran PF, Madill-Thomsen KS, Bohmig G, Bromberg J, Budde K, Barner M, Mackova M, Chang J, Einecke G, Eskandary F, Gupta G, Myslak M, Viklicky O, Akalin E, Alhamad T, Anand S, Arnol M, Baliga R, Banasik M, Bingaman A, Blosser CD, Brennan D, Chamienia A, Chow K, Ciszek M, de Freitas D, Deborska-Materkowska D, Debska-Slizien A, Djamali A, Domanski L, Durlik M, Fatica R, Francis I, Fryc J, Gill J, PMID 39117038
- Mengel M, Loupy A, Haas M, Roufosse C, Naesens M, Akalin E, Clahsen-van Groningen MC, Dagobert J, Demetris AJ, Duong van Huyen JP, Gueguen J, Issa F, Robin B, Rosales I, Von der Thusen JH, Sanchez-Fueyo A, Smith RN, Wood K, Adam B, Colvin RB. Banff 2019 Meeting Report: Molecular diagnostics in solid organ transplantation-Consensus for the Banff Human Organ Transplant (B-HOT) gene panel and open so PMID 32428337
- Zielinski D, Goutaudier V, Sablik M, Divard G, Aubert O, Piedrafita A, Mezine F, Dagobert J, Certain A, Robin B, Gueguen J, Rabant M, Duong van Huyen JP, Sannier A, Randoux-Lebrun C, Maanaoui M, Lionet A, Gibier JB, Gnemmi V, Le Quintrec M, Chauveau B, Vermorel A, Couzi L, Bestard O, Elias M, Louis K, Rosales IA, Smith RN, Kung VL, Anglicheau D, Legendre C, Del Bello A, Huang E, Adam B, Kamar N, C PMID 40345499
- Fichtner A, Gauche L, Susal C, Tran TH, Waldherr R, Krupka K, Guzzo I, Carraro A, Oh J, Zirngibl M, Weitz M, Konig J, Buscher A, Berta L, Simon T, Awan A, Rusai K, Topaloglu R, Peruzzi L, Printza N, Kim JJ, Weber LT, Melk A, Pape L, Rieger S, Patry C, Hocker B, Tonshoff B; CERTAIN study group. Incidence, risk factors, management strategies, and outcomes of antibody-mediated rejection in pediatric PMID 39283519
Identifiers
NCT: NCT07091214 · Transcriptomics_PED_001