Oncoliq: Early Breast Cancer Detection Based on Liquid Biopsies and microRNAs
NCT ID: NCT06439940
Last Updated: 2024-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
364 participants
OBSERVATIONAL
2021-07-14
2025-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women aged 50 to 70 who attend the gynecological annual check-up
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
35 Years
FEMALE
Yes
Sponsors
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Oncoliq US Inc
INDUSTRY
Responsible Party
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Locations
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Hospital Nacional Profesor Alejandro Posadas
El Palomar, Morón, Buenos Aires, Argentina
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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459 EMnP0S0 / 21
Identifier Type: -
Identifier Source: org_study_id
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