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Clinical Trials/NCT04163159
NCT04163159
Unknown
Not Applicable

Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer in Patients of the Hospital San Juan de Dios From 2018 to 2020.

Universidad de Costa Rica1 site in 1 country25 target enrollmentJanuary 7, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic Breast Cancer
Sponsor
Universidad de Costa Rica
Enrollment
25
Locations
1
Primary Endpoint
Number of somatic mutation findings in circulating free DNA (cfDNA) obtained from peripheral blood (liquid biopsy)
Last Updated
6 years ago

Overview

Brief Summary

The use of circulating tumor DNA (ctDNA) as a noninvasive test for breast cancer monitoring throughout the course of the disease

Detailed Description

The concentrations of the cell free DNA (cfDNA) and somatic mutations in circulating tumor DNA (ctDNA) in serial samples correlate with the number of days of the progression-free period and with the overall survival.

Registry
clinicaltrials.gov
Start Date
January 7, 2019
End Date
November 30, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Metastatic breast cancer before the start of chemotherapeutic treatment

Exclusion Criteria

  • Patients with incomplete clinical records

Outcomes

Primary Outcomes

Number of somatic mutation findings in circulating free DNA (cfDNA) obtained from peripheral blood (liquid biopsy)

Time Frame: 12 months

Samples will be analyze with targeted NGS sequencing panel

Assessment of circulating free DNA (cfDNA) concentration (in ng/uL) obtained from peripheral blood (liquid biopsy).

Time Frame: 12 months

Samples will be analyze with Real time PCR and fluorometric assay and compare with overall survival

Secondary Outcomes

  • Estrogen Receptor (ER), Progesterone Receptor (PR), Human Epidermal Growth Factor Receptor 2 (HER2) status(24 months)
  • Cancer stage of participant(24 months)
  • Overall survival of participant(24 months)

Study Sites (1)

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