Oncoliq blood test for early detection of breast cancer
Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | Female |
| Sponsor | Oncoliq US Inc Industry-sponsored |
| Locations | 1 site (Buenos Aires, Buenos Aires) |
| Trial ID | NCT07331506 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Earlier exploratory and preliminary confirmatory studies by the developers reported roughly 82% sensitivity and 83% specificity, indicating promising preliminary results but requiring further validation.
Eligibility criteria
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 this trial is running
Buenos Aires, Buenos Aires
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.