ClinicalTrials.Veeva

Menu

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

B

Barretos Cancer Hospital

Status

Completed

Conditions

Biomarkers
Kidney Cancer
Gene Expression

Treatments

Diagnostic Test: Gene expression test using nanostring technology.

Study type

Observational

Funder types

Other

Identifiers

NCT04415697
BarretosCH-20201

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Responders
Description:
Those who present complete response, partial response, or stable disease, according to RECIST 1.1.
Treatment:
Diagnostic Test: Gene expression test using nanostring technology.
Not responders
Description:
Those who present progression disease according to RECIST 1.1.
Treatment:
Diagnostic Test: Gene expression test using nanostring technology.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems