Breast Cancer, Breast Cancer Female, Breast Carcinoma
Conditions
Keywords
early diagnosis, early detection, cancer, breast cancer, miRNAs, liquid biopsies, pilot study, pilot test, liquid biopsy, Oncoliq, machine learning, AI, RT-qPCR
Brief summary
Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs. This innovative test aims to improve the accuracy of cancer detection, thereby reducing patient mortality and healthcare costs. To develop this test, the discovery and validation phases have been completed. In addition, Machine learning and AI were used to determine the algorithm for breast cancer detection. The overall objective of this protocol is to implement a pilot test to enroll 1,000 women without a previous cancer diagnosis who are attending their annual medical check-up. To achieve this, we will develop the following specific objectives: Enroll women over age 35 who attend the gynecological annual check-up. Test the plasma of the enrolled volunteers for specific miRNA biomarkers using RT-qPCR. Perform an analysis based on artificial intelligence techniques in collaboration with IMAGO Systems (USA) on mammogram images. Compare the results obtained from the clinical check-up (BiRad from mammogram), IMAGO Systems and RT-qPCR (Oncoliq breast test). Conduct a 5-year follow-up on volunteers with pathological results from Oncoliq breast test. Participants who meet the inclusion and exclusion criteria and agree to take part in the protocol will be required to sign both pages of the Informed Consent Form and complete the Annex and Survey. Subsequently, a small blood sample of 3-5 mL will be drawn via venipuncture.
Interventions
We do not alter the patient's regular gynecological check-up in any way. The patient will undergo a mammogram and a blood draw. We will then separate a small aliquot of blood for the purposes of the research protocol.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients over 35 years old who visit the gynecological clinic for their annual mammographic check-up
Exclusion criteria
* Personal history of cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BIRADS mammography | From July 14 2021 to December 31 2024 |
Secondary
| Measure | Time frame |
|---|---|
| Level of miRNAs in blood sample detected with RT-qPCR | From March 2023 to December 2024 |
Countries
Argentina