Clear Renal Cell Cancer (< 7cm Size)NCT03694912
Development and Evaluation of High Risk Group Prediction Model in T1 Stage Renal Cell Cancer Using Molecular Biomarkers
An observational study of Clear Renal Cell Cancer (< 7cm Size), run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Clear Renal Cell Cancer (< 7cm Size)
- What is being tested?
- Partial or radical nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 426 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2018to 22 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone partial or radical nephrectomy in Severance Hospital(Sinchon) from 2018.11 and 2019.10 were selected.
Who may be able to join
- 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
Who cannot join
- Vulnerable Participants
- Those who don't agree with this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
Seoul, 03722
Won Sik Ham, MD, 82-2-2228-2313, uroham@yuhs.ac
About this study
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.
Read the detailed description
- collection of FFPE samples: collection of primary or metastatic site
- micro-dissection: only when the tumor contents are more than 90% are analyzed.
- 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
- 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
- Mutational analysis (Transcriptome sequencing with variant calling)
- 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)
- 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
- 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
- Conditions
- Clear Renal Cell Cancer (< 7cm Size)
- Being tested
- Partial or radical nephrectomy
- Keywords
- renal cell cancer, high risk group, bio-marker
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial or radical nephrectomyProcedure or surgery
The investigators perform partial or radical nephrectomy those diagnosed as RCC.
| Study group | Role | What they receive |
|---|---|---|
| Aggressive RCC Group | RCC with synchronous metastasis, recurrence, or cancer-specific death Receives: Procedure: Partial or radical nephrectomy | |
| Non-aggressive RCC Group | RCC without synchronous metastasis, recurrence, or cancer-specific death Receives: Procedure: Partial or radical nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week after the procedure
Secondary outcomes (2)
association of tumor size
association of tumor size (Fuhrman grade 1-2: low, 3-4: high)
Measured: 1 week after the procedure
association of tumor malignancy
association of tumor malignancy (Fuhrman grade 1-2: low, 3-4: high)
Measured: 1 week after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Nov 2018
- Primary completion22 Sep 2023 (estimated)
- Study completion22 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clear Renal Cell Cancer (< 7cm Size)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694912
- Sponsor's protocol ID
- 4-2018-0753
- Status last verified
- Sep 2019
- First submitted
- 28 Sep 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are going to share study protocol of our study, statistical analysis plan, informed consent form, and clinical study report.
Publications
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.
PubMed 33823929Park 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.
PubMed 31963294
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of High Risk Group Prediction Model in T1 Stage Renal Cell Cancer Using Molecular Biomarkers
- ClinicalTrials.gov ID
- NCT03694912
- Acronym / sponsor ID
- 4-2018-0753
- Conditions
- Clear Renal Cell Cancer (< 7cm Size)
- Keywords
- renal cell cancer, high risk group, bio-marker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 426 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 22 Sep 2023 (estimated)
- Study completion
- 22 Sep 2023 (estimated)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- collection of FFPE samples: collection of primary or metastatic site
- micro-dissection: only when the tumor contents are more than 90% are analyzed.
- 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
- 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
- Mutational analysis (Transcriptome sequencing with variant calling)
- 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)
- 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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aggressive RCC Group | – | Procedure: Partial or radical nephrectomyRCC with synchronous metastasis, recurrence, or cancer-specific death |
| Non-aggressive RCC Group | – | Procedure: Partial or radical nephrectomyRCC without synchronous metastasis, recurrence, or cancer-specific death |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone partial or radical nephrectomy in Severance Hospital(Sinchon) from 2018.11 and 2019.10 were selected.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Vulnerable Participants
- Those who don't agree with this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial or radical nephrectomyThe investigators perform partial or radical nephrectomy those diagnosed as RCC. | Procedure or surgery | Aggressive RCC Group, Non-aggressive RCC Group |
Primary outcome
Assessment of gene expression of biomarkers using reverse-transcription polymerase chain reaction (qRT-PCR) according to groups
Time frame: 1 week after the procedure
Assessment of gene expression of biomarkers using reverse-transcription polymerase chain reaction (qRT-PCR) according to groups
2 secondary outcomes
association of tumor size
Time frame: 1 week after the procedure
association of tumor malignancy
Time frame: 1 week after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Derived from this study: PubMed 33823929Park 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.
- Derived from this study: PubMed 31963294Park 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.
- Individual participant dataSharing planned: Undecided. The investigators are going to share study protocol of our study, statistical analysis plan, informed consent form, and clinical study report.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clear Renal Cell Cancer (< 7cm Size), run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of gene expression of biomarkers using reverse-transcription polymerase chain reaction (qRT-PCR) according to groups (time frame: 1 week after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694912, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.