Identification of Predictive Gene Expression Profile of Sunitinib Response in Metastatic Clear Cell Renal Carcinomas

Kidney Cancer Clinical Trial

Official title:

Identification of Predictive Gene Expression Profile of Sunitinib Rate Response in Metastatic Clear Cell Renal Carcinomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415697
• Other study ID #: BarretosCH-20201
• Status: Completed
• Start date: January 2, 2019
• Est. completion date: April 10, 2020

Study information

• Verified date: May 2020
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Biomarkers
• Carcinoma, Renal Cell
• Gene Expression
• Kidney Cancer
• Kidney Neoplasms

Intervention

Diagnostic Test:
• Gene expression test using nanostring technology.
Evaluation of gene expression profile of a panel with 770 genes related to disease progression using nanostring technology

Locations

Country	Name	City	State
Brazil	Andre Octavio Nicolau Sanches	Barretos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

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