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

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Oncoliq US Inc

Status

Enrolling

Conditions

Breast Cancer
Breast Cancer Female
Breast Carcinoma

Treatments

Diagnostic Test: Blood sample extraction

Study type

Observational

Funder types

Industry

Identifiers

NCT06439940
459 EMnP0S0 / 21

Details and patient eligibility

About

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.

Enrollment

364 estimated patients

Sex

Female

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Personal history of cancer

Trial design

364 participants in 1 patient group

Women aged 50 to 70 who attend the gynecological annual check-up
Treatment:
Diagnostic Test: Blood sample extraction

Trial contacts and locations

1

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Central trial contact

Javier Stigliano, MD specialist in mastology

Data sourced from clinicaltrials.gov

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