Kidney CancerNCT04415697
Identification of Predictive Gene Expression Profile of Sunitinib Response in Metastatic Clear Cell Renal Carcinomas
An observational study of Kidney Cancer and Biomarkers, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
Renal cell carcinoma accounts for 2-3% of all cancers in western countries. Brazilian kidney cancer data show an incidence of 6,270 new cases for 2018. New target-molecular therapies have emerged in recent years for the treatment of metastatic kidney cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Biomarkers, Gene Expression
- What is being tested?
- Gene expression test using nanostring technology.
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2019to 10 Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients at least 18 years with diagnosis of metastatic clear cell renal carcinoma treated with sunitinib in Barretos Cancer Hospital between Jan/2009 and Jan/2018.
Who may be able to join
- Adult patients
- At least 18 years
- Metastatic clear cell renal carcinoma
- Primary tumors sample of nephrectomy or core biopsy
Who cannot join
- insufficient sample for molecular analysis
- Patients with no record of treatment response data
- Patients with a history of previous systemic treatment for Metastatic clear cell renal carcinoma
- Patients with second primary synchronic or metachronic tumor undergoing treatment
- Patients having received less than one cycle of sunitinib in the first line
- Patients have received previous adjuvant and/or neoadjuvant treatment with an interval < 1 year between the end of treatment and the diagnosis of metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Predictive Gene Expression Profile of Sunitinib Rate Response in Metastatic Clear Cell Renal Carcinomas
Renal cell carcinoma accounts for 2-3% of all cancers in western countries. Brazilian kidney cancer data show an incidence of 6,270 new cases for 2018. New target-molecular therapies have emerged in recent years for the treatment of metastatic kidney cancer. Due to the heterogeneity of these patients and the lack of specific markers, therapeutic is currently based on clinical and laboratory analysis. The research for predictive biomarkers may better characterize the kidney cancer therapeutic management. The objectives are to identify a predictive gene expression profile in patients with advanced clear cell renal carcinoma treated with first-line sunitinib and correlate it with rate response, seeking to identify a predictive gene expression profile. As secondary objectives, the investigators will compare the gene expression profile found, with global survival and clinical-pathological characteristics. Materials and methods: To determine through systematic data collection the epidemiological profile, clinical-pathological characteristics, response rate, disease free survival and overall survival of 60 patients with metastatic clear cell renal carcinoma who used sunitinib in the first line between 2009 and 2018 at the Barretos Cancer Hospital. For evaluation of gene expression profile, the investigators will use a panel of a panel with 770 genes related to disease progression using nanostring technology.
Keywords: Renal Cell Carcinoma; Sunitinib; Biomarkers; Gene expression; Nanostring.
- Conditions
- Kidney Cancer, Biomarkers, Gene Expression
- Being tested
- Gene expression test using nanostring technology.
- Keywords
- Kidney Cancer, Biomarkers, Gene expression, Predictive rate response, Nanostring
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene expression test using nanostring technology.Diagnostic test
Evaluation of gene expression profile of a panel with 770 genes related to disease progression using nanostring technology
| Study group | Role | What they receive |
|---|---|---|
| Responders | Those who present complete response, partial response, or stable disease, according to RECIST 1.1. Receives: Diagnostic Test: Gene expression test using nanostring technology. | |
| Not responders | Those who present progression disease according to RECIST 1.1. Receives: Diagnostic Test: Gene expression test using nanostring technology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify differentially expressed genes in two groups of objective response rate.
Identify differentially expressed genes, through the nanoString platform, in two groups of objective response rate defined using the RECIST 1.1 criteria.
Measured: One year
Secondary outcomes (1)
Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital.
Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital and correlate with data from differentially expressed genes.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start2 Jan 2019
- Primary completion20 Feb 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Octavio Nicolau Sanches, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415697
- Sponsor's protocol ID
- BarretosCH-20201
- Status last verified
- May 2020
- First submitted
- 23 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Gene Expression Profile of Sunitinib Rate Response in Metastatic Clear Cell Renal Carcinomas
- ClinicalTrials.gov ID
- NCT04415697
- Acronym / sponsor ID
- BarretosCH-20201
- Conditions
- Kidney Cancer, Biomarkers, Gene Expression
- Keywords
- Kidney Cancer, Biomarkers, Gene expression, Predictive rate response, Nanostring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 4 Jun 2020 (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.
Renal cell carcinoma accounts for 2-3% of all cancers in western countries. Brazilian kidney cancer data show an incidence of 6,270 new cases for 2018. New target-molecular therapies have emerged in recent years for the treatment of metastatic kidney cancer. Due to the heterogeneity of these patients and the lack of specific markers, therapeutic is currently based on clinical and laboratory analysis. The research for predictive biomarkers may better characterize the kidney cancer therapeutic management. The objectives are to identify a predictive gene expression profile in patients with advanced clear cell renal carcinoma treated with first-line sunitinib and correlate it with rate response, seeking to identify a predictive gene expression profile. As secondary objectives, the investigators will compare the gene expression profile found, with global survival and clinical-pathological characteristics. Materials and methods: To determine through systematic data collection the epidemiological profile, clinical-pathological characteristics, response rate, disease free survival and overall survival of 60 patients with metastatic clear cell renal carcinoma who used sunitinib in the first line between 2009 and 2018 at the Barretos Cancer Hospital. For evaluation of gene expression profile, the investigators will use a panel of a panel with 770 genes related to disease progression using nanostring technology.
Keywords: Renal Cell Carcinoma; Sunitinib; Biomarkers; Gene expression; Nanostring.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders | – | Diagnostic Test: Gene expression test using nanostring technology.Those who present complete response, partial response, or stable disease, according to RECIST 1.1. |
| Not responders | – | Diagnostic Test: Gene expression test using nanostring technology.Those who present progression disease according to RECIST 1.1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients at least 18 years with diagnosis of metastatic clear cell renal carcinoma treated with sunitinib in Barretos Cancer Hospital between Jan/2009 and Jan/2018.
Key inclusion criteria (4 listed)
- Adult patients
- At least 18 years
- Metastatic clear cell renal carcinoma
- Primary tumors sample of nephrectomy or core biopsy
Key exclusion criteria (6 listed)
- insufficient sample for molecular analysis
- Patients with no record of treatment response data
- Patients with a history of previous systemic treatment for Metastatic clear cell renal carcinoma
- Patients with second primary synchronic or metachronic tumor undergoing treatment
- Patients having received less than one cycle of sunitinib in the first line
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 |
|---|---|---|
| Gene expression test using nanostring technology.Evaluation of gene expression profile of a panel with 770 genes related to disease progression using nanostring technology | Diagnostic test | Not responders, Responders |
Primary outcome
Identify differentially expressed genes in two groups of objective response rate.
Time frame: One year
Identify differentially expressed genes, through the nanoString platform, in two groups of objective response rate defined using the RECIST 1.1 criteria.
1 secondary outcome
Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital.
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Kidney Cancer and Biomarkers, run by Barretos Cancer Hospital at 1 site in Brazil.
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 6 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: finished, as of the sponsor's last update on 4 Jun 2020. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify differentially expressed genes in two groups of objective response rate. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2020.