NCT04415697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 23, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

May 23, 2020

Last Update Submit

May 31, 2020

Conditions

Kidney CancerBiomarkersGene Expression

Keywords

Kidney CancerBiomarkersGene expressionPredictive rate responseNanostring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital.

    One Year

Study Arms (2)

Responders

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

Diagnostic Test: Gene expression test using nanostring technology.

Not responders

Those who present progression disease according to RECIST 1.1.

Diagnostic Test: Gene expression test using nanostring technology.

Interventions

Gene expression test using nanostring technology.DIAGNOSTIC_TEST

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

Not respondersResponders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adult patients
  • At least 18 years
  • Metastatic clear cell renal carcinoma
  • Primary tumors sample of nephrectomy or core biopsy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andre Octavio Nicolau Sanches

Barretos, São Paulo, 14784400, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

The samples retained in a biobank, with potential for RNA extraction, as genetic material was extracted and stored at - 80 degrees celsius, in the form of a just frozen sample/tissue.

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 23, 2020

First Posted

June 4, 2020

Study Start

January 2, 2019

Primary Completion

February 20, 2020

Study Completion

April 10, 2020

Last Updated

June 4, 2020

Record last verified: 2020-05

Locations

BR(1)