Onco-liq: Kit for Breast Cancer Diagnosis.

Sponsor

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich (Other)

Overall Status

Recruiting

CT.gov ID

NCT04906330

Collaborator

Instituto Nacional del Cáncer, Argentina (Other)

500

Enrollment

Location

Anticipated Duration (Months)

21.8

Patients Per Site Per Month

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
Breast Cancer	Diagnostic Test: Onco-liq: kit for breast cancer diagnosis.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Onco-liq: Kit for Breast Cancer Diagnosis.

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	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.	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.

Arm

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.

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.

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

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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.

Responsible Party:

Adriana De Siervi, Ph.D.; Principal Investigator, Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

ClinicalTrials.gov Identifier:

NCT04906330

Other Study ID Numbers:

V1 11.12. 2020 (C.I.R.E.C.)
IS003208

First Posted:

May 28, 2021

Last Update Posted:

Jan 27, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Adriana De Siervi, Ph.D.; Principal Investigator, Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Liquid biopsy, breast cancer, early diagnosis, microRNAs.

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jan 27, 2022