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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06439940
• Other study ID #: 459 EMnP0S0 / 21
• Status: Recruiting
• Start date: July 14, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Oncoliq US Inc
• Contact: Javier Stigliano, MD specialist in mastology
• Phone: +54 9 11 5952-7959
• Email: drstigliano[@]yahoo.com.ar
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 364
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Carcinoma
• Breast Neoplasms

Intervention

Diagnostic Test:
• Blood 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.

Locations

Country	Name	City	State
Argentina	Hospital Nacional Profesor Alejandro Posadas	El Palomar, Morón	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Oncoliq US Inc

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BIRADS mammography		From July 14 2021 to December 31 2024
Secondary	Level of miRNAs in blood sample detected with RT-qPCR		From March 2023 to December 2024