NCT07331506 Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
| NCT ID | NCT07331506 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oncoliq US Inc |
| Condition | Breast Cancer Detection |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-10-17 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-10-17 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07331506 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 70 Years, studying Breast Cancer Detection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07331506 currently recruiting?
Yes, NCT07331506 is actively recruiting participants. Contact the research team at adesiervi@oncoliq.bio for enrollment information.
Where is the NCT07331506 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina.
Who is sponsoring the NCT07331506 clinical trial?
NCT07331506 is sponsored by Oncoliq US Inc. The trial plans to enroll 300 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.