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

NCT07331506 | Recruiting

• 1 other identifier: DIM001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Detection; Breast Cancer Early Stage Breast Cancer (Stage 1-3); Breast Cancer - Female; Breast Cancer - Ductal Carcinoma in Situ (DCIS); Breast Cancer - Infiltrating Ductal Carcinoma; Breast Cancer With Low to Intermediate HER2 Expression; Breast Cancer (Early Breast Cancer)

Keywords

Breast cancer; Detection; Liquid biopsy; miRNAs

Outcome Measures

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.

  October to December 2025

Secondary Outcomes (1)

• Development of a Machine Learning Classification Algorithm

  December 2025 to March 2026

Study Arms (2)

Breast Cancer Cohort

Participants with a confirmed diagnosis of breast cancer, prior to surgery or systemic treatment.

Other: Peripheral blood draw

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

Interventions

Peripheral blood draw OTHER

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

Breast Cancer Cohort; Healthy Control Cohort

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncoliq US Inc: lead

Study Sites (1)

DIM Centros de Salud

Buenos Aires, Buenos Aires, B1704, Argentina

RECRUITING

Related Links

• 'Breast Cancer Diagnostic and Treatment'

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected and processed to obtain plasma, which will be stored for future analysis.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Adriana De Siervi, PhD in Molecular Biology

CONTACT

+54 11 3269 5832; adesiervi@oncoliq.bio

Camila Zaslavsky, Pharmacist

CONTACT

+54 11 2164 1626; camila@oncoliq.bio

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 12, 2026
• Study Start: October 17, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

AR (1)