Table 1 –
Summary of ddcfDNA studies to detect lung allograft injury or predict CLAD
| Cohort Studies Evaluating Performance Characteristics of dd-cfDNA to detect Allograft Injury in Lung Transplant Recipients | ||||||
|---|---|---|---|---|---|---|
| Authors and Date Published | Study Design | # of Patients | Approach to detect dd-cfDNA | dd-cfDNA Threshold | Primary Endpoint | Performance Characteristics |
| De Vlaminck et al. 2015 27 | Single Center Prospective Cohort Study | 51 | Two Genome Genotyping | > 1% | ACR ≥ 2R | Sensitivity: 100% Specificity: 73% AUC: 0.9 |
| Sayah et al. 2020 | Multicenter Prospective Cohort Study | 26 | Targeted SNPs | > 0.85% | ACR ≥ 1R | Sensitivity: 73% Specificity: 53% AUC: 0.72 |
| Khush et al. 2021 | Single Center Prospective Cohort Study | 38 | Targeted SNPs | > 0.85% | ACR ≥1R or AMR or BOS | Sensitivity: 56% Specificity:76% NPV: 84% AUC: 0.67 |
| Jang et al. 2021 | Multicenter Prospective Cohort Study | 148 | Two Genome Genotyping | > 1% | ACR ≥1R or AMR | Sensitivity: 77% Specificity: 84% NPV: 90% AUC: 0.89 |
| Performance of ddcfDNA to monitor for acute rejection or infection in routine clinical care | ||||||
| Authors and Date Published | Study Design | # of Patients | Approach to detect dd-cfDNA | dd-cfDNA Threshold | Primary Endpoint | Performance Characteristics |
| Keller et al. 2021 * | Multicenter Retrospective Cohort Study | 157 | Targeted SNPs | > 1% | ACR ≥1R, AMR or Infection | Sensitivity: 74% Specificity: 88% NPV: 97% AUC 0.81 |
| Association of CLAD and plasma dd-cfDNA | ||||||
| Authors and Date Published | Study Design | # of Patients | Approach to detect dd-cfDNA | Primary endpoint | Main findings | |
| Keller et al. 2021 | Multicenter Prospective Cohort Study | 99 | Two Genome Genotyping | CLAD | PGD patients who developed CLAD showed higher dd-cfDNA on Day 3 of transplant compared to PGD patients who did not develop CLAD. | |
| Bazemore et al. 2021 | Multicenter Prospective Cohort Study | 51 | Two Genome Genotyping | CLAD | CLAD associated pathogens showed higher dd-cfDNA levels compare to non-CLAD-associated pathogens | |
| Agbor-Enoh et al. 2019 | Multicenter Prospective Cohort Study | 108 | Two Genome Genotyping | Composite endpoint of CLAD or death | Patients with a higher dd-cfDNA levels in the first 3 months of transplant showed a 7-fold higher risk of allograft failure compared to patients with lower levels | |
*
Stable patients in this study not all evaluated with bronchoscopy and were considered stable by absence of signs or symptoms of allograft dysfunction over the course of the study period with at least 1–3 months follow up.