Onco-liq: Kit for Breast Cancer Diagnosis.
Study Details
Study Description
Brief Summary
Onco-liq is a novel diagnosis kit for early breast cancer detection in blood based in liquid biopsies and microRNAs. This innovative kit will allow improving the accuracy of cancer diagnosis which will impact on health, reducing the patient mortality and health costs.
To develop this kit, 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 Onco-liq has 95% specificity.
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 breast cancer early diagnosis and the management of Onco-liq positive patients.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
Diagnostic Test: Onco-liq: kit for breast cancer diagnosis.
Onco-liq is a novel diagnosis kit for early breast cancer diagnosis in blood, based on liquid biopsies and miRNAs. The main advantage of this kit 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.
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Outcome Measures
Primary Outcome Measures
- miRNA levels in plasma [Day 1]
miRNA levels in plasma will be determined by RT-qPCR using ΔΔCT method.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women patients performing gynecological control
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Between 50-70 years old
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Without personal history of oncological disease
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Informed consent signed
Exclusion Criteria:
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Patients who don´t meet the inclusion criteria.
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Active infection with SARS-CoV-2 (COVID-19).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital Militar Central | Caba | Buenos Aires | Argentina | C1426BOR |
Sponsors and Collaborators
- Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
- Instituto Nacional del Cáncer, Argentina
Investigators
- Principal Investigator: Adriana De Siervi, PhD, IBYME-CONICET
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- V1 11.12. 2020 (C.I.R.E.C.)
- IS003208