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partial or radical nephrectomy

Cheol Kwak, M.D.,Ph.D.

The aim of this study was to show additional diagnostic criteria of computed tomography (CT) scan to diagnose and predict the detection and recurrence of cystic renal cell carcinoma in the patients with complicated renal cysts. Furthermore, we would demonstrate the relationship between complicated renal cysts diagnosed by Bosniak system and some parameters of pathological results. The analysis about detection time of renal malignancy would help determine the practical guidelines of follow-up plan for complicated renal cysts.

Even though there have been many trials and errors to enhance the diagnostic accuracy of CT scans for complicated cysts, the trial to obtain the enhanced accuracy using CT scan would be still valuable, when we consider its widespread use. A previous study demonstrated that the enhancement of HU with intravenous administration of contrast material on CT scan by 15 HU would be "almost always indicative of a pathologic process although not always a malignancy", another study showed the cut-off as 42 or 47 HU gap would be helpful in the prediction of renal malignancy.

Detection of Renal Malignancy of Complicated Renal Cysts

Does Hounsfield Unit (HU) Predict the Detection of Cystic Renal Malignancy of Complicated Renal Cysts?

First, the primary outcomes is to determine cut-off values of maximal HU and the maximal gap of HU (HU of early excretory phase minus that of non-enhanced phase in CT scan)to predict the detection of renal malignancy. Some clinical factors (age, height, body weight, etc) were also included in the analysis.

Second, the above-mentioned factors were included in the analysis of risk factors for recurrence of complicated renal cysts to determine the cut-off values.

The cut-off values would show a guideline to determine the time of operation for a patient with complicated renal cysts, namely, the nephrectomy should be performed earlier if the patient is included in the high-risk group. Furthermore, the cut-off value would be helpful in the determination in what operation would be proper to the patient. A partial nephrectomy would be more beneficial to every patient than radical nephrectomy, however, if the patient is in the high-risk group for early recurrence, the patient should undergo 'radical' nephrectomy first for complicated renal cysts.

Seoul National University Hospital

Rare Diseases

Renal Cell Carcinoma

RCC with synchronous metastasis, recurrence, or cancer-specific death

RCC without synchronous metastasis, recurrence, or cancer-specific death

The investigators perform partial or radical nephrectomy those diagnosed as RCC.

Partial or radical nephrectomy

Won Sik Ham, MD

For the appropriate individualized treatment of T1-stage renal cell carcinoma with heterogeneous biological features, the expression of PBRM1, SETD2, BAP1, KDM5C and the newly proposed FOXC2 and CLIP4, are compared with clinical features. The investigators evaluated the efficacy of FOXC2 and CLIP4 as prognostic biomarkers and developed a high risk prediction model based on these results. In a previous study, the investigators evaluated the efficacy of FOXC2 and CLIP4 as prognostic biomarkers and reported their association with synchronous metastasis in renal cell carcinomas less than 7 cm in size. The investigators analyzed the expression level of renal cell carcinoma according to the size and malignancy (Fuhrman grade) of renal cell carcinoma in T1-stage clear cell type renal cell carcinoma of tumor size less than 7cm. The aim of this study was to analyze the association of tumor recurrence or metastasis, cancer specific survival rate, overall survival rate, tumor size, malignancy and T stage in postoperative biopsy. For expression analysis, PCR amplification and bidirectional Sanger sequencing and mRNA expression analysis (qRT-PCR) were used. For statistical analysis, Fisher exact test, Wilcoxon exact 2-tailed test, Cox proportional hazard regression analysis and competing risk method were used. In this study, the investigators compared the expression of PBRM1, SETD2, BAP1, and KDM5 with newly proposed biomarkers, FOXC2 and CLIP4 and demonstrate the prognostic value of FOXC2 and CLIP4 as new prognostic biomarkers and compared the clinical outcomes with the clinical outcome. Based on these results, the investigators propose a high risk prediction model for individualized treatment of T1-stage renal cell carcinoma. This study is expected to establish a new prediction model and molecular biologic stage for risk stratification of T1-stage renal cell carcinoma patients and apply genetic test for selection of optimal tailored treatment for T1-stage renal cell carcinoma. In addition, it will be an important basic data of the molecular biologic mechanism of metastasis in early renal cell carcinoma and may be used as a basic data for the development and selection of customized therapeutic agents in patients with distant metastasis.

* collection of FFPE samples: collection of primary or metastatic site
* micro-dissection: only when the tumor contents are more than 90% are analyzed.

B. Data analysis and model development

* Development goals - Analysis of prospective biomarker expression in FFPE, and frozen tissue specimens

  - Development of a high-risk prediction model for post-surgical morbidity in T1-stage RCC
  * Contents and scope

    1. Expression analysis of prospective biomarkers in FFPE and frozen tissue samples of T1-stage clear cell type RCC : PBRM1, SETD2, BAP1, and KDM5C expressed as prognostic biomarkers of renal cell carcinoma in other studies

       * The newly proposed FOXC2, CLIP4

         1. Mutational analysis (Transcriptome sequencing with variant calling)
         2. mRNA expression analysis (qRT-PCR) - only when the tumor contents are more than 90% are analyzed.

            - Analysis of tumor size and malignancy as a prognostic predictor of RCC

            - The expression of primary and metastatic lesions was analyzed by considering intratumor heterogeneity in RCC (Fisher exact test, Wilcoxon exact 2-tailed test)
            * Analysis of association with postoperative local recurrence or distant metastasis, cancer-specific survival, and overall survival (Cox proportional hazard regression analysis: Time to recurrence and distant metastasis, overall survival, competing risk method: cancer specific survival)
    2. Development of predictive model for high-risk molecular disease in T1-Stage RCC (survival rate) - elastic net Cox model in glmnet, version 1.7.3

       - prediction accuracy was evaluated using Harrel concordance probability (C-index), internal validation was performed using bootstrap
    3. Development of predictive model for preoperative molecular high risk in T1- Stage RCC (for Poor Pathologic Findings)

       * multivariate logistic/linear regression model
       * prediction accuracy was evaluated using Harrel concordance probability (C-index), internal validation was performed using bootstrap

FFPE (formalin-fixed paraffin-embedded), frozen tissue, blood, and urine samples

Development and Evaluation of High Risk Group Prediction Model in T1 Stage Renal Cell Cancer Using Molecular Biomarkers

The investigators are going to share study protocol of our study, statistical analysis plan, informed consent form, and clinical study report.

Assessment of gene expression of biomarkers using reverse-transcription polymerase chain reaction (qRT-PCR) according to groups

association of tumor size (Fuhrman grade 1-2: low, 3-4: high)

association of tumor malignancy (Fuhrman grade 1-2: low, 3-4: high)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Detection of Renal Malignancy of Complicated Renal Cysts	NCT01087060	Kidney Neoplasm Cysts Carcinoma, Rena...	partial or radi...	20 Years - 80 Years	Seoul National University Hospital
Development and Evaluation of High Risk Group Prediction Model in T1 Stage Renal Cell Cancer Using Molecular Biomarkers	NCT03694912	Clear Renal Cel...	Partial or radi...	20 Years -	Yonsei University

Spots Global Cancer Trial Database for partial or radical nephrectomy