Renal Cell Carcinoma
Conditions
Interventions
Gold Standard:Clinical outcomes
Index test:PASS model
Sponsors
Department of Urology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200127 Shanghai, China
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of resectable renal tumors under laparoscopic partial nephrectomy (the researchers judge), staging cT1a ~ 1bN0M0; 2. Preoperative examination of CTA and 99Tcm DTPA nuclear renal scintigraphy, no treatment or examination with renal toxicity (including but not limited to iodine contrast agent) within 2 weeks prior to renal scintigraphy; 3. Pathological diagnosis of renal cell carcinoma (including clear cell renal cell carcinoma, papillary renal cell carcinoma and chromophobe renal cell carcinoma); 4. 3 months of clinical and imaging studies without metastasis found (bone scan, pulmonary CT scan, abdominal CT scan + enhanced); 5. Aged 18 years to 80 years old; 6. Eastern Cooperative Oncology Group (ECOG) PS 0 or 1; 7. EORTC QLQC-30 score =2; 8. Life expectancy =2 years (investigator judgment); 9. Meet the following blood biochemical indicators: neutrophils =1500/mm^3, platelet =100000/mm^3, hemoglobin =9g/dL, bilirubin =upper limit (upper limit of normal, ULM), ALT and AST =1.5 ULM, creatinine 60ml/min); 10. Patients signed the informed consent form before entering the group.
Exclusion criteria
Exclusion criteria: 1. Participate in the study of the planning and/or carried out (in this study participants and/or staff at Renji Hospital or Renji South Hospital urologist are applicable); 2. Also included in another clinical study unless it is an observational (non-intervention) clinical study or a follow-up phase of an intervention study; 3. Malignant diseases occurring within five years, excluding the following, should be discussed with the investigator: 1) There is a history of prostate cancer with a staging = T2cN0M0 (tumor size/lymph node/metastatic staging), no biochemical recurrence or progression, and the investigators believe that no intervention is required; 2) patients who experience adequate anti-malignant tumor therapy and have low risk of recurrence (eg, surgically cured cervix in situ carcinoma, non-melanoma skin tumor, or breast ductal carcinoma); 4. Uncontrolled concurrent illnesses, including but not limited to: persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes, unstable angina, arrhythmias, and Interstitial lung disease, severe chronic gastrointestinal disorders associated with diarrhea, or psychiatric / social problems that may limit compliance with the study requirements, resulting in a significant increase in the risk of adverse events or affecting the subject's ability to provide written informed consent. 5. Any treatment including chemotherapy, immunotherapy, radiotherapy, biotherapy or hormone therapy with renal toxicity within 6 months; 6. History of allogeneic organ transplantation requiring immunosuppressive agents; 7. History of active primary immunodeficiency disease; 8. Active infection, including tuberculosis (clinical assessment, including clinical history, physical examination and radiological discovery and tuberculosis check in accordance with local operations), hepatitis B, hepatitis C, or human immunodeficiency virus (HIV, HIV 1/2 antibody positive) The Active hepatitis B virus (HBV) infection was defined as positive for HBV surface antigen (HBsAg). Previously patients with HBV infection or have been relieved (defined as the presence of hepatitis B core IgG antibody and no HBsAg, deoxyribonucleic acid [DNA] negative) were eligible. Patients with hepatitis C virus (HCV) positive antibody are eligible only if HCV ribonucleic acid (RNA) polymerase chain reaction is negative; 9. Female patients during pregnancy or lactation; 10. Patients with body weight <30 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine;GFR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Warm ischemia time;Complication;tumor size;resection volume;RENAL scores;PADUA scores;ABC category; | — |
Countries
China
Contacts
Public ContactYiran Huang
Department of Urology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed