Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer in Patients of the Hospital San Juan de Dios From 2018 to 2020.
Trial Snapshot
- Phase
- Not Applicable
- 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)
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)