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

November 21, 2019 updated by: Universidad de Costa Rica

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

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

Study Overview

Status

Unknown

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • San José, Costa Rica, 1000
        • Recruiting
        • Hospital San Juan de Dios
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Metastasic breast cancer females

Description

Inclusion Criteria:

  • Metastatic breast cancer before the start of chemotherapeutic treatment

Exclusion Criteria:

  • Patients with incomplete clinical records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estrogen Receptor (ER), Progesterone Receptor (PR), Human Epidermal Growth Factor Receptor 2 (HER2) status
Time Frame: 24 months
ER, PR, HER2 status
24 months
Overall survival of participant
Time Frame: 24 months
Overall survival of participant
24 months
Cancer stage of participant
Time Frame: 24 months
Cancer stage of participant
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • R018-SABI-00193
  • B9316 (Other Identifier: Universidad de Costa Rica)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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