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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-70
SponsorOncoliq US Inc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Peripheral blood draw

    Other intervention

    Collection of a blood sample for plasma isolation and miRNA analysis.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Breast Cancer Cohort1 intervention
Group B: Healthy Control Cohort1 intervention

Trial outcomes

Primary outcomes

1

Enrollment of 300 Participants

Successful recruitment and enrollment of a total of 300 eligible participants across both study groups within the planned recruitment period.

Time frame
October to December 2025

Secondary outcomes

1

Development of a Machine Learning Classification Algorithm

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.

Time frame
December 2025 to March 2026

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

DIM Centros de SaludRecruitingB1704, Buenos Aires, Buenos AiresArgentinaArgentina

Sponsors and contacts

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