Oncoliq: Test for Early Breast Cancer Detection.

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT04906330
• Lead Sponsor: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Brief Summary

Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs. This innovative test will allow improving the accuracy of cancer detection which will impact on health, reducing the patient mortality and health costs.

To develop this test, it has been finished the preclinical PHASE I: in laboratory animals; PHASE II: exploratory clinical phase for the discovery of candidate biomarkers in breast cancer patients and PHASE III: clinical validation of biomarkers showing that Oncoliq has 91% of sensitivity.

Currently it is been setting up a "pilot test" for breast cancer to enrol 500 woman volunteers without previous cancer diagnosis that go to the annual medical control. The results of the pilot test will give the accuracy for early breast cancer detection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Study Start: 2021-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Women patients performing gynecological control
• Between 50-70 years old
• Without personal history of oncological disease
• Informed consent signed

Exclusion Criteria

• Patients who don´t meet the inclusion criteria.
• Active infection with SARS-CoV-2 (COVID-19).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
miRNA levels in plasma	Day 1	miRNA levels in plasma will be determined by RT-qPCR.

Trial Locations

Locations (1)

Hospital Militar Central; 🇦🇷 Caba, Buenos Aires, Argentina