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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04163159
Recruitment Status : Recruiting
First Posted : November 14, 2019
Last Update Posted : November 25, 2019
Information provided by (Responsible Party):
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

Condition or disease
Metastatic Breast Cancer Mutation, Point

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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. 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

  2. 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

Secondary Outcome Measures :
  1. Estrogen Receptor (ER), Progesterone Receptor (PR), Human Epidermal Growth Factor Receptor 2 (HER2) status [ Time Frame: 24 months ]
    ER, PR, HER2 status

  2. Overall survival of participant [ Time Frame: 24 months ]
    Overall survival of participant

  3. Cancer stage of participant [ Time Frame: 24 months ]
    Cancer stage of participant

Biospecimen Retention:   Samples With DNA
Plasma and whole blood samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Metastasic breast cancer females

Inclusion Criteria:

  • Metastatic breast cancer before the start of chemotherapeutic treatment

Exclusion Criteria:

  • Patients with incomplete clinical records

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04163159

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Contact: Ricardo Chinchilla +50625113483
Contact: Allan Ramos, Msc. +50688448187

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Costa Rica
Hospital San Juan de Dios Recruiting
San José, Costa Rica, 1000
Contact: Allan E Ramos-Esquivel, MD, MSc    +50688448187   
Sponsors and Collaborators
Universidad de Costa Rica

Goss PE, Lee BL, Badovinac-Crnjevic T, Strasser-Weippl K, Chavarri-Guerra Y, St Louis J, Villarreal-Garza C, Unger-Saldaña K, Ferreyra M, Debiasi M, Liedke PE, Touya D, Werutsky G, Higgins M, Fan L, Vasconcelos C, Cazap E, Vallejos C, Mohar A, Knaul F, Arreola H, Batura R, Luciani S, Sullivan R, Finkelstein D, Simon S, Barrios C, Kightlinger R, Gelrud A, Bychkovsky V, Lopes G, Stefani S, Blaya M, Souza FH, Santos FS, Kaemmerer A, de Azambuja E, Zorilla AF, Murillo R, Jeronimo J, Tsu V, Carvalho A, Gil CF, Sternberg C, Dueñas-Gonzalez A, Sgroi D, Cuello M, Fresco R, Reis RM, Masera G, Gabús R, Ribeiro R, Knust R, Ismael G, Rosenblatt E, Roth B, Villa L, Solares AL, Leon MX, Torres-Vigil I, Covarrubias-Gomez A, Hernández A, Bertolino M, Schwartsmann G, Santillana S, Esteva F, Fein L, Mano M, Gomez H, Hurlbert M, Durstine A, Azenha G. Planning cancer control in Latin America and the Caribbean. Lancet Oncol. 2013 Apr;14(5):391-436. doi: 10.1016/S1470-2045(13)70048-2.

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Responsible Party: Universidad de Costa Rica Identifier: NCT04163159    
Other Study ID Numbers: R018-SABI-00193
B9316 ( Other Identifier: Universidad de Costa Rica )
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases