Oncoliq: Test for Early Breast Cancer Detection.

NCT ID: NCT04906330

Last Updated: 2024-02-28

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PPHM-0000-21

50-70 year old female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control.

Oncoliq: test for early breast cancer detection.

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Women patients performing gynecological control
* Between 50-70 years old
* Without personal history of oncological disease
* Informed consent signed

* Active infection with SARS-CoV-2 (COVID-19).
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Nacional del Cáncer, Argentina

OTHER_GOV

Sponsor Role collaborator

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

OTHER

Sponsor Role lead

Responsible Party

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Adriana De Siervi

Ph.D.; Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriana De Siervi, PhD

Role: PRINCIPAL_INVESTIGATOR

IBYME-CONICET

Locations

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Hospital Militar Central

CABA, Buenos Aires, Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Adriana De Siervi, PhD

Role: CONTACT

+54 911 3269-5832

Juana Moro, MD

Role: CONTACT

+54 9 11 5181-3320

Facility Contacts

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Emilio Batagelj, MD

Role: primary

+54 9 113779-0638

Related Links

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Other Identifiers

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IS003208

Identifier Type: REGISTRY

Identifier Source: secondary_id

V1 11.12. 2020 (C.I.R.E.C.)

Identifier Type: -

Identifier Source: org_study_id

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