Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
NCT ID: NCT07331506
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-10-17
2026-02-28
Brief Summary
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MicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and are found both inside cells and in bodily fluids such as blood and urine. Several studies have demonstrated their role in human diseases, especially cancer, where tumors release miRNAs into the bloodstream that can be used as biomarkers for early detection.
The research and development team at Oncoliq SAS identified a panel of miRNAs associated with breast cancer, with a detection performance of 82% sensitivity and 83% specificity, validated in exploratory and preliminary confirmatory studies. These results led to the filing of a patent based on liquid biopsy technology.
The objective of this protocol is to establish a panel of miRNAs for the early detection of breast cancer using samples from breast cancer patients and a cancer-free control group. Validation of the miRNAs will be carried out through RT-qPCR. This stage constitutes the analytical validation of the biomarkers, with the goal of developing an algorithm capable of classifying individuals with and without breast cancer. In future stages, a pilot clinical trial is planned to evaluate test implementation and clinical validation.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Breast Cancer Cohort
Participants with a confirmed diagnosis of breast cancer, prior to surgery or systemic treatment.
Peripheral blood draw
Collection of a blood sample for plasma isolation and miRNA analysis.
Healthy Control Cohort
Cancer-free volunteers confirmed by breast imaging (BI-RADS 1 or 2) and without a prior history of cancer.
Peripheral blood draw
Collection of a blood sample for plasma isolation and miRNA analysis.
Interventions
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Peripheral blood draw
Collection of a blood sample for plasma isolation and miRNA analysis.
Eligibility Criteria
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Inclusion Criteria
Age between 40 and 70 years Diagnosis of breast cancer at any stage No prior surgical treatment No prior antineoplastic treatment Pathology report available at the time of enrollment Signed informed consent
Group 2 - No Cancer (Control):
Age between 50 and 70 years No diagnosis or personal history of any type of cancer Digital mammography and breast ultrasound showing no breast pathology (BI-RADS 1 or 2) Signed informed consent
Exclusion Criteria
40 Years
70 Years
FEMALE
Yes
Sponsors
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Oncoliq US Inc
INDUSTRY
Responsible Party
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Locations
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DIM Centros de Salud
Buenos Aires, Buenos Aires, Argentina
Countries
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Central Contacts
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Facility Contacts
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Related Links
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'Breast Cancer Diagnostic and Treatment'
Other Identifiers
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DIM001
Identifier Type: -
Identifier Source: org_study_id
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