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Oncoliq: Early Breast Cancer Detection Based on Liquid Biopsies and microRNAs

Pilot Test for an Early Diagnosis Kit for Breast Cancer Based on Liquid Biopsies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06439940
Enrollment
364
Registered
2024-06-03
Start date
2021-07-14
Completion date
2025-03-31
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Cancer Female, Breast Carcinoma

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

DIAGNOSTIC_TESTBlood sample extraction

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

Oncoliq US Inc
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frame
BIRADS mammographyFrom July 14 2021 to December 31 2024

Secondary

MeasureTime frame
Level of miRNAs in blood sample detected with RT-qPCRFrom March 2023 to December 2024

Countries

Argentina

Contacts

Primary ContactJavier Stigliano, MD specialist in mastology
drstigliano@yahoo.com.ar+54 9 11 5952-7959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026