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Application of VDJ detection in the evaluation of micro-residue after treatment of blood tumor and the prediction of virus infection after transplantation

Application of VDJ detection in the evaluation of micro-residue after treatment of blood tumor and the prediction of virus infection after transplantation

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073011
Enrollment
Unknown
Registered
2023-06-29
Start date
2023-04-06
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

neoplastic hematologic disorder

Interventions

For the first test, peripheral blood was sampled before transplantation, Immune group library TCR sequencing:N/A
The second test, the first peripheral blood after transplantation, Immune group library TCR sequencing:N/A
The third test, the second peripheral blood collection after transplantation, Immune group library TCR sequencing:N/A

Sponsors

Department of Hematology, Fifth Medical Center, Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Receptor inclusion criteria: 1) Age =14 years old, gender unlimited; 2) Recipients that meet the requirements for hematopoietic stem cell transplantation; 3) Hematopoietic stem cell transplant recipients must have received hematopoietic stem cell transplantation; 4) ECOG score less than or equal to 1; 5) Major organ function is normal, meeting the following definitions: Blood routine examination: neutrophil count = 1.0 x 10^9/L, small blood Plate = 75 x 10^9/L, hemoglobin = 80 g/dL; Liver and kidney function: AST and ALT = 3.0 upper limit of normal value; Bilirubin =2.0 mg/dL; Creatinine clearance = 60 mL/min; Liver and kidney function impairment caused by tumor compression was not restricted. 6) Consent to use effective contraceptive methods; 7) Understand and voluntarily sign written informed consent. Donor admission criteria: 1) Age =14 years old, gender unlimited; 2) Donors that meet the requirements for hematopoietic stem cell transplantation; 3) Adequate venous access is available for peripheral blood leucocyte separation, or consent to the use of temporary central venous catheter for leucocyte separation; 4) Voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: Receptor exclusion criteria: 1) have other tumors (excluding non-melanoma skin cancer and in situ cervical cancer, bladder cancer, and breast cancer with disease-free survival of more than 5 years); 2) People with severe mental disorders; 3) A history or disease of the central nervous system, such as seizure disorder, cerebral ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the CNS; 4) There is an infection that needs to be treated, and the infection should be controlled before re-admission; 5) Any of the following virological test results are positive: human immunodeficiency virus, hepatitis C virus, hepatitis B virus surface antigen, hepatitis B surface core antibody; 6) Patients with severe allergic history or allergic constitution; 7) There are other active malignant tumors that may interfere with the study and require treatment; 8) According to the investigators, the patient had other conditions that were not suitable for enrollment. Donor exclusion criteria: 1) A history of mental disorders that may affect compliance with this Agreement or inability to sign informed consent; 2) A history of uncontrolled high blood pressure, stroke, or serious heart disease (other than angina). Asymptomatic donors with a history of coronary artery bypass grafting or angioplasty will be evaluated in cardiology; 3) There is anemia or small blood plate symptoms. Donors with Hb level < 110g/L due to iron deficiency are eligible for donation after starting iron supplementation. 4) Any of the following virological surveillance results are positive: HIV; HCV; HbsAg; HBcAb; 5) Pregnant donor; 6) any other circumstances deemed unsuitable for inclusion by the researcher;

Design outcomes

Primary

MeasureTime frame
VDJ gene;

Secondary

MeasureTime frame
TCR/BCR diversity;

Countries

CHINA

Contacts

Public Contactjian bo

Chinese PLA General Hospita

boj301@sina.com+86 138 1053 5576

Outcome results

None listed

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