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

Sponsor
Barretos Cancer Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04415697
Collaborator
(none)
60
1
15.2
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Gene expression test using nanostring technology.

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Identification of Predictive Gene Expression Profile of Sunitinib Rate Response in Metastatic Clear Cell Renal Carcinomas
Actual Study Start Date :
Jan 2, 2019
Actual Primary Completion Date :
Feb 20, 2020
Actual Study Completion Date :
Apr 10, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Identify differentially expressed genes in two groups of objective response rate. [One year]

    Identify differentially expressed genes, through the nanoString platform, in two groups of objective response rate defined using the RECIST 1.1 criteria.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Andre Octavio Nicolau Sanches Barretos Sao Paulo Brazil 14784400

Sponsors and Collaborators

  • Barretos Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andre Octavio Nicolau Sanches, Medical Doctor, Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT04415697
Other Study ID Numbers:
  • BarretosCH-20201
First Posted:
Jun 4, 2020
Last Update Posted:
Jun 4, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andre Octavio Nicolau Sanches, Medical Doctor, Barretos Cancer Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 4, 2020