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An Observational Study of Longitudinal Serum Proteomic and Metabolomic Profiling to Identify Biomarkers Associated With Immunotherapy Response in Advanced Metastatic Renal Cell Carcinoma

An Observational Study of Longitudinal Serum Proteomic and Metabolomic Profiling to Identify Biomarkers Associated With Immunotherapy Response in Advanced Metastatic Renal Cell Carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120306
Enrollment
Unknown
Registered
2026-03-12
Start date
2026-03-15
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Kidney Cancer

Interventions

case series:No

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in this study and signing the informed consent form; 2. Male or female, aged 18 years or older and under 80 years; 3. Diagnosed as clear cell carcinoma or clear cell carcinoma predominant renal cell carcinoma through histopathological examination; 4. Clinical CT or MR staging as any TN1M0 or any TN0M1; IMDC score = 3.5 × 10^9/L, absolute neutrophil count >= 1.5 × 10^9/L, PLT >= 75.0 × 10^9/L, HGb >= 80g/L; - Cardiac function: Cardiac function 0-2 grades; - Liver function: Total bilirubin = 45 ml/min; 8. Willing and able to follow the trial and follow-up procedures.

Exclusion criteria

Exclusion criteria: 1. Non-transparent cell carcinoma; 2. Severe liver and kidney dysfunction, combined with other serious diseases; 3. Known to have severe cardiovascular diseases, including any of the following conditions: a myocardial infarction or arterial inflammation or venous thrombosis event (such as pulmonary embolism) occurred in the past 1 year; severe/ unstable angina pectoris; uncontrollable hypertension; heart failure, reaching NYHA standard level III or IV; drug-induced ventricular arrhythmia; 4. History of immunodeficiency diseases (including positive HIV test, other acquired or congenital immune deficiency diseases) or history of organ transplantation or autoimmune diseases; 5. History of severe central nervous system diseases. History of epilepsy or any disease that may induce epilepsy, including unexplained loss of consciousness or transient ischemic attack; 6. Combined with other malignant tumors in the past 5 years, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 7. Unable to cooperate with regular follow-up observation due to psychological, social, family and geographical reasons.

Design outcomes

Primary

MeasureTime frame
Diagnostic Accuracy of Serum Biomarker Signature in Predicting Response to Immunotherapy;Correlation Between Serum Biomarker Levels and Objective Response Rate (ORR) ;Association of Serum Biomarker Signatures with Progression-Free Survival (PFS);Sensitivity;Speciificity;

Countries

China

Contacts

Public ContactZhai Wei

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

jacky_zw2002@hotmail.com+86 187 0177 1959

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026