Validation of the Oncoliq Test for the Early Detection of Breast Cancer.

January 13, 2026 updated by: Oncoliq US Inc

Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. However, the lack of accessible, low-cost, non-invasive, non-toxic, and easy-to-implement diagnostic methods results in late diagnoses, leading to 1 in every 6 people dying from cancer today.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

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

  • Name: Adriana De Siervi, PhD in Molecular Biology
  • Phone Number: +54 11 3269 5832
  • Email: adesiervi@oncoliq.bio

Study Contact Backup

  • Name: Camila Zaslavsky, Pharmacist
  • Phone Number: +54 11 2164 1626
  • Email: camila@oncoliq.bio

Study Locations

  • Argentina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, B1704
        • Recruiting
        • DIM Centros de Salud
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of two groups of female participants. Group 1 (Breast Cancer): Women aged 40-70 years with a confirmed diagnosis of breast cancer at any stage, prior to any surgical or antineoplastic treatment, and with a pathology report available at enrollment.

Group 2 (Control - No Cancer): Women aged 50-70 years with no current or past history of cancer and normal breast imaging findings (digital mammography and breast ultrasound, Bi-RADS 1/2).

All participants must be able to provide written informed consent. Exclusion criteria include inability to understand the study procedures, medical conditions that make venipuncture unsafe or unfeasible, and any prior history of cancer.

Description

Inclusion Criteria:

Group 1 - Breast Cancer:

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:

Refusal to sign the informed consent Communication issues that hinder understanding (hearing loss, blindness, intellectual disability, or dementia) Venipuncture for blood collection impracticable or posing a risk Personal history of previous cancer

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer Cohort
Participants with a confirmed diagnosis of breast cancer, prior to surgery or systemic treatment.
Other: 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.
Other: Peripheral blood draw
Collection of a blood sample for plasma isolation and miRNA analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment of 300 Participants
Time Frame: October to December 2025
Successful recruitment and enrollment of a total of 300 eligible participants across both study groups within the planned recruitment period.
October to December 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of a Machine Learning Classification Algorithm
Time Frame: December 2025 to March 2026
Creation and validation of a machine learning model capable of distinguishing between individuals with breast cancer and cancer-free controls based on blood-derived biomarkers.
December 2025 to March 2026

Collaborators and Investigators

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

Sponsor

Oncoliq US Inc

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.

Helpful Links

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)

October 17, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIM001

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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