Breast Cancer FemaleNCT06439940
Oncoliq: Early Breast Cancer Detection Based on Liquid Biopsies and microRNAs
An observational study of Breast Cancer Female and Breast Cancer, run by Oncoliq US Inc at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, Breast Cancer, Breast Carcinoma
- What is being tested?
- Blood sample extraction
- How many people
- 364 participants
- Where
- 1 siteArgentina
- Study dates
- 14 Jul 2021to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This protocol includes female volunteers over 35 years old with no personal history of oncological disease who visit the gynecology unit at \"Hospital Posadas\" for a gynecological and mammographic check-up.
Who may be able to join
- Patients over 35 years old who visit the gynecological clinic for their annual mammographic check-up
Who cannot join
- Personal history of cancer
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Nacional Profesor Alejandro Posadas
El Palomar, Morón, Buenos Aires, B1684
Javier Stigliano, MD specialist in mastology, +549 11 5952 7959, drstigliano@yahoo.com.ar
Javier Stigliano, MD specialist in mastology
About this study
Official title: Pilot Test for an Early Diagnosis Kit for Breast Cancer Based on Liquid Biopsies
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.
Read more
The overall objective of this protocol is to implement a pilot test to enroll 1,000 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.
- Conditions
- Breast Cancer Female, Breast Cancer, Breast Carcinoma
- Being tested
- Blood sample extraction
- Keywords
- early diagnosis, early detection, cancer, breast cancer, miRNAs, liquid biopsies, pilot study, pilot test, liquid biopsy, Oncoliq, machine learning, AI, RT-qPCR
- Medical subject headings
- Breast Neoplasms, Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample extractionDiagnostic test
We do not alter the patient\'s regular gynecological check-up in any way. The patient will undergo a mammogram and a blood draw. We will then separate a small aliquot of blood for the purposes of the research protocol.
| Study group | Role | What they receive |
|---|---|---|
| Women aged 50 to 70 who attend the gynecological annual check-up | Not described Receives: Diagnostic Test: Blood sample extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIRADS mammography
Measured: From July 14 2021 to December 31 2024
Secondary outcomes (1)
Level of miRNAs in blood sample detected with RT-qPCR
Measured: From March 2023 to December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start14 Jul 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncoliq US Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439940
- Sponsor's protocol ID
- 459 EMnP0S0 / 21
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test for an Early Diagnosis Kit for Breast Cancer Based on Liquid Biopsies
- ClinicalTrials.gov ID
- NCT06439940
- Acronym / sponsor ID
- 459 EMnP0S0 / 21
- Conditions
- Breast Cancer Female, Breast Cancer, Breast Carcinoma
- Keywords
- early diagnosis, early detection, cancer, breast cancer, miRNAs, liquid biopsies, pilot study, pilot test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Oncoliq US IncIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 1,000 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women aged 50 to 70 who attend the gynecological annual check-up | – | Diagnostic Test: Blood sample extraction |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This protocol includes female volunteers over 35 years old with no personal history of oncological disease who visit the gynecology unit at \"Hospital Posadas\" for a gynecological and mammographic check-up.
Key inclusion criteria (1 listed)
- Patients over 35 years old who visit the gynecological clinic for their annual mammographic check-up
Key exclusion criteria (1 listed)
- Personal history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample extractionWe do not alter the patient\'s regular gynecological check-up in any way. The patient will undergo a mammogram and a blood draw. We will then separate a small aliquot of blood for the purposes of the research protocol. | Diagnostic test | Women aged 50 to 70 who attend the gynecological annual check-up |
Primary outcome
BIRADS mammography
Time frame: From July 14 2021 to December 31 2024
1 secondary outcome
Level of miRNAs in blood sample detected with RT-qPCR
Time frame: From March 2023 to December 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Breast Cancer, run by Oncoliq US Inc at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Stigliano, MD specialist in mastology (+54 9 11 5952-7959, drstigliano@yahoo.com.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIRADS mammography (time frame: From July 14 2021 to December 31 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.