Clinical trial NCT04415697: Identification of Predictive Gene Expression Profile of Sunitinib Response in Metastatic Clear Cell Renal Carcinomas
Official title: Identification of Predictive Gene Expression Profile of Sunitinib Rate Response in Metastatic Clear Cell Renal Carcinomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Biomarkers
Gene Expression
Keywords: Kidney Cancer
Biomarkers
Gene expression
Predictive rate response
Nanostring
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* At least 18 years
* Metastatic clear cell renal carcinoma
* Primary tumors sample of nephrectomy or core biopsy

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Identify differentially expressed genes in two groups of objective response rate.
timeFrame: One year
Secondary outcomes:
measure: Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital.
timeFrame: One Year
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Andre Octavio Nicolau Sanches
state: Sao Paulo
Study officials:
References: