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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04415697
Other study ID # BarretosCH-20201
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2019
Est. completion date April 10, 2020

Study information

Verified date May 2020
Source Barretos Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 10, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Brazil Andre Octavio Nicolau Sanches Barretos Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital. 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
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