Heart transplant, Lung Transplant, Liver transplant, Kidney Transplant, Pancreas Transplant
Conditions
Interventions
None listed
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This information outlines the eligibility criteria for the study: Target Diseases: The study includes individuals who are either newly receiving organ transplants (heart, lung, liver, pancreas, kidney, or small intestine) or have already received organ transplants. Patient Background Information (e.g., Age and Gender): Patients who provided consent are 18 years or older at the time of consent. For liver transplant patients, consent can be obtained when the patient is under 3 years of age. The age at the time of transplantation is not specifically mentioned, as long as it fulfills the conditions mentioned above. Consent Obtained in Writing: The consent for participation in the study is obtained in written form. Additional Notes: Specific details regarding disease classification (duration of illness, disease stage, disease type, severity, etc.), hospitalization or outpatient status, previous treatments, and recurrence are not specified. The study primarily focuses on single-organ transplant patients. However, exceptions are made for pancreas-kidney simultaneous transplant patients and liver-small intestine simultaneous transplant patients, as there are limited cases of pancreas and small intestine transplants. Pancreas-kidney simultaneous transplant patients are registered as pancreas transplant patients, and liver-small intestine simultaneous transplant patients are registered as small intestine transplant patients. No specific clinical, geographical, or temporal criteria are mentioned as eligibility criteria for the study.
Exclusion criteria
Exclusion criteria: The provided information outlines certain exclusion criteria for the study: 1. Pregnancy: Pregnant individuals are excluded from participation. 2. Twin-to-Twin Transplants: Cases involving twin-to-twin transplants are not eligible. 3. History of Bone Marrow Transplant: Individuals with a history of bone marrow transplant are not included. 4. Multiple Organ Transplants: The study primarily focuses on single-organ transplant patients. However, exceptions are made for pancreas-kidney simultaneous transplant patients and liver-small intestine simultaneous transplant patients. 5. Re-transplantation: Patients who have undergone re-transplantation are excluded from the study. Note regarding Multiple Organ Transplants: The study allows for exceptions in cases of pancreas-kidney simultaneous transplant patients and liver-small intestine simultaneous transplant patients. These patients may be eligible for registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This research involves the following key analyses in the context of six organ transplantations: 1.Analysis of acute-phase changes in donor-derived cell-free DNA (cfDNA) in the acute period, with a focus on detecting ischemia-reperfusion injury and recording changes until the stable phase. Record baseline values after acute-phase changes. 2.Analysis of factors influencing baseline values, including age, HLA mismatch count, gender, surgery duration, ischemia time, type of immunosuppressive drugs, physical differences, organ-specific assessment criteria, CMV status, and initial immunosuppressive agents. 3.Survival analysis for one year post-transplantation based on grouping the donor-derived cfDNA values obtained using the baseline value (value one month post-transplant). 4.Correlation analysis between measured donor-derived cfDNA and the degree of rejection reaction in the transplanted organs. 5.Correlation analysis between measured donor-derived cfDNA and organ function assessment criteria or existing markers. 6.Analysis of donor-derived cfDNA values corresponding to the timing of tissue sample collection based on histological diagnostic criteria in each major organ transplantation, comparing these values between i) rejection reaction groups (ACR/AMR/CR), ii) non-rejection reaction groups (organ dysfunctions other than rejection reactions), and iii) groups without histological abnormalities. 7.ROC curve analysis: Conduct ROC analysis between the above-mentioned groups to determine sensitivity, specificity, positive predictive value, and negative predictive value. 8.Perform multivariate analysis by combining donor-derived cfDNA, patient profiles, organ-specific information for transplanted organs, post-transplant treatment methods, and other factors to assess whether donor-derived cfDNA is an independent predictor of transplantation outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| For the purpose of diagnosing organ dysfunctions, including rejection reactions, samples collected at the time of diagnosis and post-diagnosis are analyzed to track the changes in donor-derived cfDNA due to treatment interventions. Grouping based on baseline donor-derived cfDNA values (e.g., using a cutoff value of 0.5%) and illustrating the occurrence of de novo Donor Specific Antibodies (dnDSA) using a Kaplan-Meier plot. The horizontal axis represents the number of days after the initial test, while the vertical axis represents the rate of dnDSA occurrence. Analyzing the risk of donor-derived cfDNA and dnDSA occurrence using a Cox proportional hazards model and determining hazard ratios. The cutoff value will be determined for each organ. This analysis aims to understand how changes in donor-derived cfDNA relate to the development of dnDSA in the context of organ dysfunctions, allowing for the determination of risk and potential interventions based on baseline values. | — |
Countries
Japan
Contacts
Public ContactYohei Yamada
Keio University School of Medicine Department of Pediatric Surgery
Outcome results
None listed