Breast Cancer DetectionNCT07331506
Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
An observational study of Breast Cancer Detection and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Oncoliq US Inc at 1 site in Argentina.
Trial summary
Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Detection, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Female
- What is being tested?
- Peripheral blood draw
- How many people
- 300 participants
- Where
- 1 siteArgentina
- Study dates
- 17 Oct 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of two groups of female participants. Group 1 (Breast Cancer): Women aged 40-70 years with a confirmed diagnosis of breast cancer at any stage, prior to any surgical or antineoplastic treatment, and with a pathology report available at enrollment. Group 2 (Control - No Cancer): Women aged 50-70 years with no current or past history of cancer and normal breast imaging findings (digital mammography and breast ultrasound, Bi-RADS 1/2). All participants must be able to provide written informed consent. Exclusion criteria include inability to understand the study procedures, medical conditions that make venipuncture unsafe or unfeasible, and any prior history of cancer.
Who may be able to join
- Group 1 - Breast Cancer:
- Age between 40 and 70 years Diagnosis of breast cancer at any stage No prior surgical treatment No prior antineoplastic treatment Pathology report available at the time of enrollment Signed informed consent
- Group 2 - No Cancer (Control):
- Age between 50 and 70 years No diagnosis or personal history of any type of cancer Digital mammography and breast ultrasound showing no breast pathology (BI-RADS 1 or 2) Signed informed consent
Who cannot join
- Refusal to sign the informed consent Communication issues that hinder understanding (hearing loss, blindness, intellectual disability, or dementia) Venipuncture for blood collection impracticable or posing a risk Personal history of previous cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
DIM Centros de Salud
Buenos Aires, Buenos Aires, B1704
Maria Abril Acosta, Oncologist, +54 11 6376-7387, acostamariaabril@gmail.com
About this study
Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. However, the lack of accessible, low-cost, non-invasive, non-toxic, and easy-to-implement diagnostic methods results in late diagnoses, leading to 1 in every 6 people dying from cancer today.
MicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and are found both inside cells and in bodily fluids such as blood and urine. Several studies have demonstrated their role in human diseases, especially cancer, where tumors release miRNAs into the bloodstream that can be used as biomarkers for early detection.
Read more
The research and development team at Oncoliq SAS identified a panel of miRNAs associated with breast cancer, with a detection performance of 82% sensitivity and 83% specificity, validated in exploratory and preliminary confirmatory studies. These results led to the filing of a patent based on liquid biopsy technology.
The objective of this protocol is to establish a panel of miRNAs for the early detection of breast cancer using samples from breast cancer patients and a cancer-free control group. Validation of the miRNAs will be carried out through RT-qPCR. This stage constitutes the analytical validation of the biomarkers, with the goal of developing an algorithm capable of classifying individuals with and without breast cancer. In future stages, a pilot clinical trial is planned to evaluate test implementation and clinical validation.
- Conditions
- Breast Cancer Detection, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Female, Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast Cancer - Infiltrating Ductal Carcinoma, Breast Cancer With Low to Intermediate HER2 Expression
- Being tested
- Peripheral blood draw
- Keywords
- Breast cancer, Detection, Liquid biopsy, miRNAs
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood drawOther
Collection of a blood sample for plasma isolation and miRNA analysis.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Cohort | Participants with a confirmed diagnosis of breast cancer, prior to surgery or systemic treatment. Receives: Other: Peripheral blood draw | |
| Healthy Control Cohort | Cancer-free volunteers confirmed by breast imaging (BI-RADS 1 or 2) and without a prior history of cancer. Receives: Other: Peripheral blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment of 300 Participants
Successful recruitment and enrollment of a total of 300 eligible participants across both study groups within the planned recruitment period.
Measured: October to December 2025
Secondary outcomes (1)
Development of a Machine Learning Classification Algorithm
Creation and validation of a machine learning model capable of distinguishing between individuals with breast cancer and cancer-free controls based on blood-derived biomarkers.
Measured: December 2025 to March 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start17 Oct 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer DetectionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 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
- NCT07331506
- Sponsor's protocol ID
- DIM001
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 15 Jan 2026
- 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
- ClinicalTrials.gov ID
- NCT07331506
- Acronym / sponsor ID
- DIM001
- Conditions
- Breast Cancer Detection, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Female, Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast Cancer - Infiltrating Ductal Carcinoma, Breast Cancer With Low to Intermediate HER2 Expression
- Keywords
- Breast cancer, Detection, Liquid biopsy, miRNAs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oncoliq US IncIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 12 Jan 2026 (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.
Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. However, the lack of accessible, low-cost, non-invasive, non-toxic, and easy-to-implement diagnostic methods results in late diagnoses, leading to 1 in every 6 people dying from cancer today.
MicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and are found both inside cells and in bodily fluids such as blood and urine. Several studies have demonstrated their role in human diseases, especially cancer, where tumors release miRNAs into the bloodstream that can be used as biomarkers for early detection.
The research and development team at Oncoliq SAS identified a panel of miRNAs associated with breast cancer, with a detection performance of 82% sensitivity and 83% specificity, validated in exploratory and preliminary confirmatory studies. These results led to the filing of a patent based on liquid biopsy technology.
The objective of this protocol is to establish a panel of miRNAs for the early detection of breast cancer using samples from breast cancer patients and a cancer-free control group. Validation of the miRNAs will be carried out through RT-qPCR. This stage constitutes the analytical validation of the biomarkers, with the goal of developing an algorithm capable of classifying individuals with and without breast cancer. In future stages, a pilot clinical trial is planned to evaluate test implementation and clinical validation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Cohort | – | Other: Peripheral blood drawParticipants with a confirmed diagnosis of breast cancer, prior to surgery or systemic treatment. |
| Healthy Control Cohort | – | Other: Peripheral blood drawCancer-free volunteers confirmed by breast imaging (BI-RADS 1 or 2) and without a prior history of cancer. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of two groups of female participants. Group 1 (Breast Cancer): Women aged 40-70 years with a confirmed diagnosis of breast cancer at any stage, prior to any surgical or antineoplastic treatment, and with a pathology report available at enrollment. Group 2 (Control - No Cancer): Women aged 50-70 years with no current or past history of cancer and normal breast imaging findings (digital mammography and breast ultrasound, Bi-RADS 1/2). All participants must be able to provide written informed consent. Exclusion criteria include inability to understand the study procedures, medical conditions that make venipuncture unsafe or unfeasible, and any prior history of cancer.
Key inclusion criteria (4 listed)
- Age between 40 and 70 years Diagnosis of breast cancer at any stage No prior surgical treatment No prior antineoplastic treatment Pathology report available at the time of enrollment Signed informed consent
- Age between 50 and 70 years No diagnosis or personal history of any type of cancer Digital mammography and breast ultrasound showing no breast pathology (BI-RADS 1 or 2) Signed informed consent
Key exclusion criteria (1 listed)
- Refusal to sign the informed consent Communication issues that hinder understanding (hearing loss, blindness, intellectual disability, or dementia) Venipuncture for blood collection impracticable or posing a risk Personal history of previous 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 |
|---|---|---|
| Peripheral blood drawCollection of a blood sample for plasma isolation and miRNA analysis. | Other | Breast Cancer Cohort, Healthy Control Cohort |
Primary outcome
Enrollment of 300 Participants
Time frame: October to December 2025
Successful recruitment and enrollment of a total of 300 eligible participants across both study groups within the planned recruitment period.
1 secondary outcome
Development of a Machine Learning Classification Algorithm
Time frame: December 2025 to March 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- 'Breast Cancer Diagnostic and Treatment'Link 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.
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 Detection and Breast Cancer Early Stage Breast Cancer (Stage 1-3), 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 4 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adriana De Siervi, PhD in Molecular Biology (+54 11 3269 5832, adesiervi@oncoliq.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment of 300 Participants (time frame: October to December 2025). 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 15 Jan 2026.