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Serum extracellular vesicles derived miRNAs function as early diagnosis and disease progression markers of clear cell renal cell carcinoma

Serum extracellular vesicles derived miRNAs function as early diagnosis and disease progression markers of clear cell renal cell carcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036568
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

Renal cell carcinoma

Interventions

Gold Standard:Pathologic diagnosis
Index test:Serum&#32

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The subject voluntarily joins the study, signs an informed consent form, has good compliance, and cooperates with follow-up; 2. Male or female aged >= 18 years and = 4 x 10^9/L; medium Sex granulocytes >= 2 x 10^9/L; HB >= 90 g/L; ANC >= 1.5 x 10^9/L; PLT >= 100 x 10^9/L; (2) Non-functional organic diseases, which must meet the following criteria: T-BIL 30ml/min (Cockcroft-Gault formula); international normalized ratio (INR), activated partial thromboplastin time (aPTT): = 60mL/min according to the Cockcroft-Gault formula.

Exclusion criteria

Exclusion criteria: 1. previously received anti-PD-1, anti-PD-L1, and anti-CTLA-4 treatments, including adjuvant therapy; 2. those who are known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; 3. before the start of research treatment Have received other anti-tumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical research within 4 weeks, or have not recovered from the last toxicity (except for 2nd degree alopecia and 1st degree neurotoxicity); 4. pregnancy or lactation Women; 5. HIV test results are positive; patients with active hepatitis B or C; 6. have a clear history of active tuberculosis; 7. have active autoimmune diseases that require systemic treatment in the past 2 years (such as the use of disease modifiers, corticosteroids or Immunosuppressive drugs), allowing related replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for renal or pituitary insufficiency); 8. other serious and uncontrollable concomitants that may affect protocol compliance or interfere with the interpretation of results Diseases, including active opportunistic infections or advanced (severe) infections, uncontrollable diabetes, cardiovascular disease (grade III or IV heart failure defined by the New York Heart Association classification, heart block above II degree, past 6 Myocardial infarction, unstable arrhythmia or unstable angina within months, cerebral infarction within 3 months, etc.) or lung disease (history of interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm); 7. excluded Subjects with active central nervous system (CNS) metastasis; 8. those who received live vaccination within 4 weeks before the start of treatment; have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 9. those who have undergone a large-scale disease within 4 weeks before treatment Surgery (excluding diagnostic surgery); 10. people with a history of psychotropic drug abuse and unable to abstain or with a history of mental disorders; 11. accompanied by clinical symptoms or a large amount of pleural fluid or ascites requiring symptomatic treatment; 12. suffering from other malignant tumors that has not healed in the past 5 years.

Design outcomes

Primary

MeasureTime frame
extracellular vesicles;miRNA;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactZhai Wei

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

jackyzw2007@163.com+86 18701771959

Outcome results

None listed

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