Oncoliq: Test for Early Breast Cancer Detection. | NCT04906330

Studies
Oncoliq: Test for Early Breast Cancer Detection.

NCT04906330

Sponsor

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Status

Unknown status

Last Update Posted

Feb 28, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Oncoliq: test for early breast cancer detection.

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IS003208	Registry Identifier	RENIS

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Aug 1, 2024Estimated

Completion Date

Aug 1, 2025Estimated

First Submitted Date

May 13, 2021

First Submission Date that Met QC Criteria

May 25, 2021

First Posted Date

May 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2024

Last Update Posted Date

Feb 28, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Hospital Militar Central Cirujano Mayor Dr. Cosme ArgerichOTHER

Collaborators

Name	Class
Instituto Nacional del Cáncer, Argentina	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: Oncoliq: test for early breast cancer detection.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oncoliq: test for early breast cancer detection.	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
miRNA levels in plasma	miRNA levels in plasma will be determined by RT-qPCR.	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Adriana De Siervi, PhD	Contact	+54 911 3269-5832		adrianadesiervi@gmail.com
Juana Moro, MD	Contact	+54 9 11 5181-3320		morojuana@gmail.com

Overall Officials

Name	Affiliation	Role
Adriana De Siervi, PhD	IBYME-CONICET	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Militar Central	Recruiting	CABA	Buenos Aires	C1426BOR	Argentina

References Module

Citations

Not provided

Label	URL
Notice in a local online newspaper	View source
Notice in a local TV-news program	View source

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases