Oncoliq blood test for early detection of breast cancer
Official title: Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
Run by Oncoliq US Inc · NCT07331506 · Data updated 2026-11-12
This project will test whether a blood-based miRNA panel (the Oncoliq Test) can detect early breast cancer in adults 40–70 by comparing newly diagnosed, untreated patients with cancer-free controls.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years to 70 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Oncoliq US Inc Industry-sponsored |
| Locations | 1 site (Buenos Aires, Buenos Aires) |
| Status | Recruiting |
| Started | October 17, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | February 28, 2026 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT07331506 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 40–70 with a new breast cancer diagnosis who have not yet had surgery or anti-cancer treatment, and cancer-free controls aged 50–70 with normal mammogram and ultrasound.
✕Probably not a fit
People with a prior history of cancer, those who have already received surgery or systemic treatment for their breast cancer, or anyone unable to safely provide a blood sample are unlikely to gain benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational case-control study collects peripheral blood to measure a panel of circulating microRNAs that Oncoliq identified as associated with breast cancer. It enrolls two groups: people aged 40–70 with newly diagnosed, untreated breast cancer and cancer-free controls aged 50–70 with normal mammography and ultrasound. Researchers will compare the miRNA profiles to pathology and imaging results to validate diagnostic performance. Prior exploratory and preliminary confirmatory work reported about 82% sensitivity and 83% specificity, and this study aims to confirm those findings in a clinical population at a Buenos Aires site.
Why it matters
Potential benefit: If successful, the test could offer a simple, non-invasive blood screen to detect breast cancer earlier and help reduce late diagnoses.
How similar studies have gone: Earlier exploratory and preliminary confirmatory studies by the developers reported roughly 82% sensitivity and 83% specificity, indicating promising preliminary results but requiring further validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
DIM Centros de Salud
Buenos Aires, Buenos Aires, Argentina Recruiting
Study contacts
- Study coordinator: Adriana De Siervi, PhD in Molecular Biology
- Email: adesiervi@oncoliq.bio
- Phone: +54 11 3269 5832
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.