Kidney Cancer Clinical Trial
Official title:
Identification of Predictive Gene Expression Profile of Sunitinib Rate Response in Metastatic Clear Cell Renal Carcinomas
Verified date | May 2020 |
Source | Barretos Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 10, 2020 |
Est. primary completion date | February 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Andre Octavio Nicolau Sanches | Barretos | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Barretos Cancer Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | One year | |
Secondary | 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. | One Year |
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