Oncoliq: Test for Early Breast Cancer Detection.
2 other identifiers
observational
500
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedFebruary 28, 2024
February 1, 2024
2.9 years
May 13, 2021
February 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
miRNA levels in plasma
miRNA levels in plasma will be determined by RT-qPCR.
Day 1
Study Arms (1)
PPHM-0000-21
50-70 year old female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control.
Interventions
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.
Eligibility Criteria
Female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control.
You may qualify if:
- Women patients performing gynecological control
- Between 50-70 years old
- Without personal history of oncological disease
- Informed consent signed
You may not qualify if:
- Active infection with SARS-CoV-2 (COVID-19).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Militar Central
CABA, Buenos Aires, C1426BOR, Argentina
Related Links
Biospecimen
The plasma from participants will be obtained by centrifugation of blood collected with EDTA, and retained in a -80 ° C freezer exclusively for laboratory use and under lock and key. Samples will be codified and labelled.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adriana De Siervi, PhD
IBYME-CONICET
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D.; Principal Investigator
Study Record Dates
First Submitted
May 13, 2021
First Posted
May 28, 2021
Study Start
September 1, 2021
Primary Completion
August 1, 2024
Study Completion
August 1, 2025
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share