Renal Cell Carcinoma
Conditions
Interventions
Observation group:None
We aim to observe:
1. Patients' MRD test results
2.Preoperative and postoperative status of Patients' MRD
3.Comparison between the time of suggested recurrence by MRD and imagin
Sponsors
The Second Affiliated Hospital of Naval Medical University(Shanghai Changzheng Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Have been fully informed about the study and voluntarily signed an informed consent form; (2) Age 18 years - to 75 years old, male and female; (3) Tumors could be radically resected, no obvious metastatic foci were seen in preoperative chest CT, abdominal enhanced CT, ECT and PET-CT, and there was no evidence of residual disease in postoperative imaging; (4)Patients who are proposed to undergo partial nephrectomy according to the American Joint Committee on Cancer (AJCC) 8th edition preclinical TNM staging of renal cancer at stage T1b-T2b with one of the following features: a. Imaging studies suggesting a high degree of tumor malignancy, including lobulated tumors and combined hemorrhagic necrosis. b. Tumor located in special location, including renal hilar and renal sinus, as seen on imaging or intraoperatively; c. Postoperative tumor pathology suggests the type of renal cell carcinoma containing high malignancy and invasiveness, including sarcomatoid dedifferentiated clear cell renal cell carcinoma, collecting duct carcinoma, renal medullary carcinoma; d. Renal cancer assessed as intermediate risk or high risk by the UISS prognostic grading system for renal cancer (5) Patients with preclinical TNM staging of renal cancer according to the American Joint Committee on Cancer (AJCC) 8th edition as stage T1b-T4 with one of the following features, who are proposed to undergo radical nephrectomy for renal cancer: a. Intermediate-risk and high-risk as assessed by the UISS prognostic grading system for renal cancer; b. Patients with preoperative imaging showing tumor combined with venous cancerous embolus (below the diaphragm) or suspected positive abdominal lymph nodes can be included regardless of the size of the patient's tumor whenever the operator judges that the lesion can be radically resected. (6) Patients with double kidney cancer or multiple kidney cancers whose tumors can undergo simultaneous radical surgery; (7) Requirement for the proportion of operative modality enrollment: no less than 35% of the two types of radical nephrectomy and partial nephrectomy for renal cancer; Requirement for the proportion of pathologic subtype enrollment: no less than 70% of the proportion of renal clear cell carcinoma enrollment;
Exclusion criteria
Exclusion criteria: (1) The patient's tumor has developed distant metastasis, including distant lymph node metastasis that cannot be radically resected, organ metastasis (except for the ipsilateral adrenal gland) and bone metastasis; (2) Bilateral renal cancer that cannot be treated at the same time; (3) Patients who are proposed to undergo partial nephrectomy but have a low-risk UISS score (i.e., stage T1, nuclear classification 1-2, ECOG=0); (4) Combination of other tumors throughout the body; (5) Preoperative antitumor therapy; (6) Patients who have previously undergone partial nephrectomy or radical nephrectomy; (7) Non-recurrent patients with less than 12 months of follow-up; (8) Suffering from poor general condition with the presence of one of the following conditions: including severe mental disorders, cardiovascular disease, active infections, bone marrow transplantation within 3 months, or significant abnormalities in organ function; (9) Participation in other clinical studies or previous treatment with any gene therapy product within the last three months; (10) Other conditions that the researchers believe may affect the experimental results or violate ethics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Molecular residual disease;recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| warning time of MRD prior to imaging suggesting recurrent metastasis ;ctDNA status duration; | — |
Countries
China
Contacts
Public ContactRen Shancheng
The Second Affiliated Hospital of Naval Medical University(Shanghai Changzheng Hospital)
Outcome results
None listed