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Clinical study of microchimerism and cfDNA as biomarkers for acute rejection after organ transplantation

Clinical study of microchimerism and cfDNA as biomarkers for acute rejection after organ transplantation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDD-17010635
Enrollment
Unknown
Registered
2017-02-15
Start date
2017-03-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Organ transplant rejection

Interventions

Gold Standard:Pathologic biopsy is the gold standard to diagnose acute rejection. Pathological diagnosis and classification criteria of acute rejection after renal transplantation: Classification of a
Index test:Microchimerism&#32
and&#32

Sponsors

Fuzhou general hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Single-organ transplant patients between the ages of 18 and 65 (both included) years old; 2. Patients ,with no potential infection in vivo lesions, who can tolerate single organ transplant surgery; 3. Organs donors without mental disorders and between the ages of 18 and 60 (both included) years have the statutory kinship with the recipient, and whose conditions are in line with the standards of Regulations on Human Organ Transplantation; 4. Donor organs in line with the standards of organ donation after the death of Chinese citizens between the ages of 18 to 60 years; 5. Informed consent is obtained from the patient or his family members.

Exclusion criteria

Exclusion criteria: 1. Patients in need of combined transplantation of more than one organ; 2. ABO blood group incompatible transplantation; 3. Pregnant women or women going to give birth or breastfeed in the next two years, or women whose pre-enrollment pregnancy test was positive before drug studies; 4. Donors or recipients are known to be hepatitis C antibody positive or HCV RNA positive; 5. The patient and / or donor is known to have a human immunodeficiency virus infection (HIV); 6. Patients had a risk of tuberculosis (TB); 7. Patients had any significant infection or other contraindications; 8. Patients with a history of drug abuse (narcotics or alcohol) or psychiatric disorders in the past 6 months can not be followed up adequately; 9. Patients with active peptic ulcer disease (PUD); 10. Patients took any investigational drugs within the 30 days before the first survey.

Design outcomes

Primary

MeasureTime frame
microchimerism;cfDNA;

Countries

China

Contacts

Public ContactJian-Ming Tan

Organ transplantation institute, Fuzhou general hospital

tanjm156@xmu.edu.cn+86 13375918000

Outcome results

None listed

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