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

NCT06439940 | Recruiting

• 1 other identifier: 459 EMnP0S0 / 21
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Breast Cancer; 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

Outcome Measures

Primary Outcomes (1)

• BIRADS mammography

  From July 14 2021 to December 31 2024

Secondary Outcomes (1)

• Level of miRNAs in blood sample detected with RT-qPCR

  From March 2023 to December 2024

Study Arms (1)

Women aged 50 to 70 who attend the gynecological annual check-up

Diagnostic Test: Blood sample extraction

Interventions

Blood sample extraction DIAGNOSTIC_TEST

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.

Women aged 50 to 70 who attend the gynecological annual check-up

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This protocol includes female volunteers over 35 years old with no personal history of oncological disease who visit the gynecology unit at \"Hospital Posadas\" for a gynecological and mammographic check-up.

You may qualify if:

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

You may not qualify if:

• Personal history of cancer

Sponsors & Collaborators

• Oncoliq US Inc: lead

Study Sites (1)

Hospital Nacional Profesor Alejandro Posadas

El Palomar, Morón, Buenos Aires, B1684, Argentina

RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

MeSH Terms

Conditions

Breast Neoplasms; Disease; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Javier Stigliano, MD specialist in mastology

CONTACT

+54 9 11 5952-7959; drstigliano@yahoo.com.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: July 14, 2021
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

AR (1)