Development and Evaluation of High Risk Group Prediction Model in T1 Stage Renal Cell Cancer Using Molecular Biomarkers
1 other identifier
observational
426
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 3, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2023
CompletedSeptember 17, 2019
September 1, 2019
4.9 years
September 28, 2018
September 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of gene expression of biomarkers using reverse-transcription polymerase chain reaction (qRT-PCR) according to groups
Assessment of gene expression of biomarkers using reverse-transcription polymerase chain reaction (qRT-PCR) according to groups
1 week after the procedure
Secondary Outcomes (2)
association of tumor size
1 week after the procedure
association of tumor malignancy
1 week after the procedure
Study Arms (2)
Aggressive RCC Group
RCC with synchronous metastasis, recurrence, or cancer-specific death
Non-aggressive RCC Group
RCC without synchronous metastasis, recurrence, or cancer-specific death
Interventions
The investigators perform partial or radical nephrectomy those diagnosed as RCC.
Eligibility Criteria
Patients who have undergone partial or radical nephrectomy in Severance Hospital(Sinchon) from 2018.11 and 2019.10 were selected.
You may qualify if:
- Patients diagnosed as clear cell renal cell caner T1 stage
- Patients who have undergone partial or radical nephrectomy in Severance Hospital, Sinchon from 2018.11 and 2019.10
- Those who agree to give permission to use their human source information
- Those who agree with this study
You may not qualify if:
- Vulnerable Participants
- Those who don't agree with this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
Seoul, 03722, South Korea
Related Publications (2)
Park JS, Jang WS, Kim J, Lee SH, Rha KH, Ham WS. Association between visceral adiposity and DDX11 as a predictor of aggressiveness of small clear-cell renal-cell carcinoma: a prospective clinical trial. Cancer Metab. 2021 Apr 6;9(1):15. doi: 10.1186/s40170-021-00251-y.
PMID: 33823929DERIVEDPark JS, Pierorazio PM, Lee JH, Lee HJ, Lim YS, Jang WS, Kim J, Lee SH, Rha KH, Cho NH, Ham WS. Gene Expression Analysis of Aggressive Clinical T1 Stage Clear Cell Renal Cell Carcinoma for Identifying Potential Diagnostic and Prognostic Biomarkers. Cancers (Basel). 2020 Jan 16;12(1):222. doi: 10.3390/cancers12010222.
PMID: 31963294DERIVED
Biospecimen
FFPE (formalin-fixed paraffin-embedded), frozen tissue, blood, and urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2018
First Posted
October 3, 2018
Study Start
November 1, 2018
Primary Completion
September 22, 2023
Study Completion
September 22, 2023
Last Updated
September 17, 2019
Record last verified: 2019-09