Clinical trial NCT04163159: Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer Patients in Costa Rica
Official title: Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer in Patients of the Hospital San Juan de Dios From 2018 to 2020.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Breast Cancer
Mutation, Point
Lead sponsor: Universidad de Costa Rica
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastasic breast cancer females

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.

Eligibility criteria: Inclusion Criteria:

* Metastatic breast cancer before the start of chemotherapeutic treatment

Exclusion Criteria:

* Patients with incomplete clinical records

Primary outcomes:
measure: Assessment of circulating free DNA (cfDNA) concentration (in ng/uL) obtained from peripheral blood (liquid biopsy).
timeFrame: 12 months
measure: Number of somatic mutation findings in circulating free DNA (cfDNA) obtained from peripheral blood (liquid biopsy)
timeFrame: 12 months
Secondary outcomes:
measure: Estrogen Receptor (ER), Progesterone Receptor (PR), Human Epidermal Growth Factor Receptor 2 (HER2) status
timeFrame: 24 months
measure: Overall survival of participant
timeFrame: 24 months
measure: Cancer stage of participant
timeFrame: 24 months
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Hospital San Juan de Dios
Study officials:
References:
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