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

May 31, 2020 updated by: Andre Octavio Nicolau Sanches, Barretos Cancer Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784400
        • Andre Octavio Nicolau Sanches

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Responders
Those who present complete response, partial response, or stable disease, according to RECIST 1.1.
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
Not responders
Those who present progression disease according to RECIST 1.1.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify differentially expressed genes in two groups of objective response rate.
Time Frame: One year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital.
Time Frame: One Year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2019

Primary Completion (ACTUAL)

February 20, 2020

Study Completion (ACTUAL)

April 10, 2020

Study Registration Dates

First Submitted

May 23, 2020

First Submitted That Met QC Criteria

May 31, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 31, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BarretosCH-20201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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