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NCT04906330 Clinical Trial

Oncoliq: Test for Early Breast Cancer Detection.

Breast Cancer Clinical Trial

Official title:
Oncoliq: Test for Early Breast Cancer Detection.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04906330
Other study ID # V1 11.12. 2020 (C.I.R.E.C.)
Secondary ID IS003208
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date August 1, 2025

Study information
Verified date February 2024
Source Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Contact Adriana De Siervi, PhD
Phone +54 911 3269-5832
Email adrianadesiervi@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date August 1, 2025
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Oncoliq: test for early breast cancer detection.
Oncoliq is a novel early detection breast cancer test based on liquid biopsies and miRNAs. The main advantage of this test is that miRNAs released from the tumor into the bloodstream can be detected in the plasma of patients even when the tumor is undetectable by other methods.

Locations
Country Name City State
Argentina Hospital Militar Central Caba Buenos Aires

Sponsors (2)
Lead Sponsor Collaborator
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Instituto Nacional del Cáncer, Argentina

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary miRNA levels in plasma miRNA levels in plasma will be determined by RT-qPCR. Day 1
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