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

NCT ID: NCT04415697

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2020-04-10

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.

Conditions

Kidney Cancer; Biomarkers; Gene Expression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Responders

Those who present complete response, partial response, or stable disease, according to RECIST 1.1.

Gene expression test using nanostring technology.

Intervention Type: DIAGNOSTIC_TEST

Evaluation of gene expression profile of a panel with 770 genes related to disease progression using nanostring technology

Not responders

Those who present progression disease according to RECIST 1.1.

Gene expression test using nanostring technology.

Intervention Type: DIAGNOSTIC_TEST

Evaluation of gene expression profile of a panel with 770 genes related to disease progression using nanostring technology

Interventions

Gene expression test using nanostring technology.

Evaluation of gene expression profile of a panel with 770 genes related to disease progression using nanostring technology

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barretos Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andre Octavio Nicolau Sanches

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Andre Octavio Nicolau Sanches

Barretos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

BarretosCH-20201

Identifier Type: -

Identifier Source: org_study_id