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

Recruiting

• Conditions: Breast Carcinoma; Breast Cancer Female; Breast Cancer
• Interventions: Diagnostic Test: Blood sample extraction

• Registration Number: NCT06439940
• Lead Sponsor: Oncoliq US Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-14
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-31
• Status Verified: 2024-06
• Study First Posted: 2024-06-03
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 364

Inclusion Criteria

• Patients over 35 years old who visit the gynecological clinic for their annual mammographic check-up

Exclusion Criteria

• Personal history of cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women aged 50 to 70 who attend the gynecological annual check-up	Blood sample extraction	-

Primary Outcome Measures

Name	Time	Method
BIRADS mammography	From July 14 2021 to December 31 2024

Secondary Outcome Measures

Name	Time	Method
Level of miRNAs in blood sample detected with RT-qPCR	From March 2023 to December 2024

Trial Locations

Locations (1)

Hospital Nacional Profesor Alejandro Posadas; 🇦🇷 El Palomar, Morón, Buenos Aires, Argentina