Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer Patients in Costa Rica

• Conditions: Metastatic Breast Cancer; Mutation, Point

• Registration Number: NCT04163159
• Lead Sponsor: Universidad de Costa Rica

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.

Study Timeline

• Study Start: 2019-01-07
• Status Verified: 2019-11
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25
• Primary Completion: 2020-10-31
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Metastatic breast cancer before the start of chemotherapeutic treatment

Exclusion Criteria

• Patients with incomplete clinical records

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of somatic mutation findings in circulating free DNA (cfDNA) obtained from peripheral blood (liquid biopsy)	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).	12 months	Samples will be analyze with Real time PCR and fluorometric assay and compare with overall survival

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital San Juan de Dios; 🇨🇷 San José, Costa Rica