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An Exploratory Study of Donor-derived Cell-free DNA Detection Based on Indel and Amplicon Library Construction for Early-stage Monitoring of Immune Rejection after Kidney Transplantation

An Exploratory Study of Donor-derived Cell-free DNA Detection Based on Indel and Amplicon Library Construction for Early-stage Monitoring of Immune Rejection after Kidney Transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069276
Enrollment
Unknown
Registered
2023-03-11
Start date
2023-03-11
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune rejection after kidney transplantation

Interventions

Sponsors

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Single kidney transplantation; 2. Had not received other organ transplantation operations before enrollment; 3. No gender limit, aged over 18 and under 70 years; 4. Had not received chemotherapy within one year before enrollment; 5. No blood transfusion was received within 1 month before each sampling; 6. Patients who are willing to comply with all trial requirements and agree to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who were pregnant, nursing or planning to become pregnant during the trial; 2. Patients with a life expectancy of less than 13 months, or who are determined by the investigator to be unsuitable for diagnostic monitoring through scheduled blood collection; 3. Patients with multiple organ transplantation; 4. Patients with malignant tumors; 5. Patients who have participated in other clinical trials in the past 6 months; 6. Patients with infection before transplant operation; 7. Transplants between identical twins; 8. Patients who have received bone marrow transplants.

Design outcomes

Primary

MeasureTime frame
donor-derived cell-free DNA;sensitivity;specificity;negative predictive value;positive predictive value;

Countries

China

Contacts

Public ContactYuan Xiaodong

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

sdyuanxd@126.com+86 21 5388 2042

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026