Breast Cancer DetectionNCT07331506
Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
An observational study of Breast Cancer Detection and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Oncoliq US Inc at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Detection, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Female
- What is being tested?
- Peripheral blood draw
- How many people
- 300 participants
- Where
- 1 siteArgentina
- Study dates
- 17 Oct 2025to 28 Feb 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
DIM Centros de Salud
Buenos Aires, Buenos Aires, B1704
Maria Abril Acosta, Oncologist, +54 11 6376-7387, acostamariaabril@gmail.com
About this study
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.
Read more
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
- Being tested
- Peripheral blood draw
- Keywords
- Breast cancer, Detection, Liquid biopsy, miRNAs
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood drawOther
Collection of a blood sample for plasma isolation and miRNA analysis.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Cohort | Participants with a confirmed diagnosis of breast cancer, prior to surgery or systemic treatment. Receives: 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. Receives: Other: Peripheral blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment of 300 Participants
Successful recruitment and enrollment of a total of 300 eligible participants across both study groups within the planned recruitment period.
Measured: 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.
Measured: December 2025 to March 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start17 Oct 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncoliq US Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331506
- Sponsor's protocol ID
- DIM001
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided