Actively Recruiting
Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
Led by Oncoliq US Inc · Updated on 2026-01-15
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Cancer remains a major global health challenge, with late diagnosis contributing to high mortality. Researchers are evaluating a panel of microRNAs (miRNAs) found in blood that may help detect breast cancer early. These miRNAs regulate gene expression and tumors release them into the bloodstream, making them potential biomarkers. The study aims to validate these miRNAs to develop a test for early breast cancer detection using liquid biopsy technology. Participants include women diagnosed with breast cancer before any surgery or treatment, and a cancer-free control group confirmed by breast imaging. Blood samples will be collected to isolate plasma for miRNA analysis. The study will focus on analytical validation of the biomarkers through RT-qPCR and seek to develop an algorithm to distinguish individuals with and without breast cancer. The study runs from October 2025 to February 2026. Participants will provide blood samples for testing and researchers will analyze these samples to validate the miRNA panel. The main goal is to enroll 300 participants between October and December 2025, followed by development of a machine learning algorithm from December 2025 to March 2026. Study involvement includes blood collection and imaging confirmation for controls. The trial is observational and does not involve treatment or intervention beyond sample collection.
CONDITIONS
Brief Title
Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For breast cancer group: Women aged 40 to 70 years
- Diagnosed with breast cancer at any stage
- No prior surgery or antineoplastic treatment
- Pathology report available at enrollment
- Signed informed consent
- For control group: Women aged 50 to 70 years
- No personal history or diagnosis of any cancer
- Recent digital mammography and breast ultrasound showing no breast pathology (BI-RADS 1 or 2)
- Signed informed consent
You will not qualify if you...
- Refusal to sign informed consent
- Communication difficulties such as hearing loss, blindness, intellectual disability, or dementia
- Blood draw not possible or posing health risk
- Personal history of previous cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants provide a blood sample for plasma isolation and miRNA analysis.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
DIM Centros de Salud
Buenos Aires, Buenos Aires, Argentina, B1704
Actively Recruiting
Research Team
A
Adriana De Siervi, PhD in Molecular Biology
C
Camila Zaslavsky, Pharmacist
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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