Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439940
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-28
Brief Title:
Oncoliq Early Breast Cancer Detection Based on Liquid Biopsies and microRNAs
Sponsor:
Oncoliq US Inc
Organization:
Oncoliq US Inc
Study Overview
Official Title:
Pilot Test for an Early Diagnosis Kit for Breast Cancer Based on Liquid Biopsies
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs This innovative test aims to improve the accuracy of cancer detection thereby reducing patient mortality and healthcare costs
To develop this test the discovery and validation phases have been completed In addition Machine learning and AI were used to determine the algorithm for breast cancer detection
The overall objective of this protocol is to implement a pilot test to enroll 1000 women without a previous cancer diagnosis who are attending their annual medical check-up
To achieve this we will develop the following specific objectives
Enroll women over age 35 who attend the gynecological annual check-up Test the plasma of the enrolled volunteers for specific miRNA biomarkers using RT-qPCR
Perform an analysis based on artificial intelligence techniques in collaboration with IMAGO Systems USA on mammogram images
Compare the results obtained from the clinical check-up BiRad from mammogram IMAGO Systems and RT-qPCR Oncoliq breast test Conduct a 5-year follow-up on volunteers with pathological results from Oncoliq breast test
Participants who meet the inclusion and exclusion criteria and agree to take part in the protocol will be required to sign both pages of the Informed Consent Form and complete the Annex and Survey Subsequently a small blood sample of 3-5 mL will be drawn via venipuncture
To develop this test the discovery and validation phases have been completed In addition Machine learning and AI were used to determine the algorithm for breast cancer detection
The overall objective of this protocol is to implement a pilot test to enroll 1000 women without a previous cancer diagnosis who are attending their annual medical check-up
To achieve this we will develop the following specific objectives
Enroll women over age 35 who attend the gynecological annual check-up Test the plasma of the enrolled volunteers for specific miRNA biomarkers using RT-qPCR
Perform an analysis based on artificial intelligence techniques in collaboration with IMAGO Systems USA on mammogram images
Compare the results obtained from the clinical check-up BiRad from mammogram IMAGO Systems and RT-qPCR Oncoliq breast test Conduct a 5-year follow-up on volunteers with pathological results from Oncoliq breast test
Participants who meet the inclusion and exclusion criteria and agree to take part in the protocol will be required to sign both pages of the Informed Consent Form and complete the Annex and Survey Subsequently a small blood sample of 3-5 mL will be drawn via venipuncture
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None