Oncoliq: Test for Early Breast Cancer Detection.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Adriana De Siervi, PhD
- Phone Number: +54 911 3269-5832
- Email: adrianadesiervi@gmail.com
Study Contact Backup
- Name: Juana Moro, MD
- Phone Number: +54 9 11 5181-3320
- Email: morojuana@gmail.com
Study Locations
-
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Buenos Aires
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Caba, Buenos Aires, Argentina, C1426BOR
- Recruiting
- Hospital Militar Central
-
Contact:
- Emilio Batagelj, MD
- Phone Number: +54 9 113779-0638
- Email: ebatagelj@yahoo.com.ar
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women patients performing gynecological control
- Between 50-70 years old
- Without personal history of oncological disease
- Informed consent signed
Exclusion Criteria:
- Patients who don´t meet the inclusion criteria.
- Active infection with SARS-CoV-2 (COVID-19).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PPHM-0000-21
50-70 year old female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
miRNA levels in plasma
Time Frame: Day 1
|
miRNA levels in plasma will be determined by RT-qPCR.
|
Day 1
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Adriana De Siervi, PhD, IBYME-CONICET
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V1 11.12. 2020 (C.I.R.E.C.)
- IS003208 (Registry Identifier: RENIS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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