Breast CancerNCT04906330
Oncoliq: Test for Early Breast Cancer Detection.
An observational study of Breast Cancer, run by Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich 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 will allow improving the accuracy of cancer detection which will impact on health, reducing the patient mortality and health costs. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Oncoliq: test for early breast cancer detection.
- How many people
- 500 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Sep 2021to 1 Aug 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control.
Who may be able to join
- Women patients performing gynecological control
- Between 50-70 years old
- Without personal history of oncological disease
- Informed consent signed
Who cannot join
- Patients who don´t meet the inclusion criteria.
- Active infection with SARS-CoV-2 (COVID-19).
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Militar Central
CABA, Buenos Aires, C1426BOR
Emilio Batagelj, MD, +54 9 113779-0638, ebatagelj@yahoo.com.ar
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- Oncoliq: test for early breast cancer detection.
- Keywords
- Liquid biopsy, breast cancer, early detection, microRNAs.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| PPHM-0000-21 | 50-70 year old female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control. Receives: Diagnostic Test: Oncoliq: test for early breast cancer detection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA levels in plasma
miRNA levels in plasma will be determined by RT-qPCR.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Sep 2021
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional del Cáncer, Argentina
- Responsible party
- Principal investigator, Adriana De Siervi, Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
- Investigators
- Adriana De Siervi, PhD, Principal investigator, IBYME-CONICET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906330
- Sponsor's protocol ID
- V1 11.12. 2020 (C.I.R.E.C.)
- Other IDs
- IS003208
- Status last verified
- Feb 2024
- First submitted
- 13 May 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncoliq: Test for Early Breast Cancer Detection.
- ClinicalTrials.gov ID
- NCT04906330
- Acronym / sponsor ID
- V1 11.12. 2020 (C.I.R.E.C.)
- Conditions
- Breast Cancer
- Keywords
- Liquid biopsy, breast cancer, early detection, microRNAs.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Militar Central Cirujano Mayor Dr. Cosme ArgerichUniversity, hospital or other
- Collaborators
- Instituto Nacional del Cáncer, Argentina
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 28 May 2021 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPHM-0000-21 | – | Diagnostic Test: Oncoliq: test for early breast cancer detection.50-70 year old female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control.
Key inclusion criteria (4 listed)
- Women patients performing gynecological control
- Between 50-70 years old
- Without personal history of oncological disease
- Informed consent signed
Key exclusion criteria (2 listed)
- Patients who don´t meet the inclusion criteria.
- Active infection with SARS-CoV-2 (COVID-19).
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 |
|---|---|---|
| Oncoliq: test for early breast cancer detection.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. | Diagnostic test | PPHM-0000-21 |
Primary outcome
miRNA levels in plasma
Time frame: Day 1
miRNA levels in plasma will be determined by RT-qPCR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Notice in a local online newspaperLink provided by the sponsor.
- Notice in a local TV-news programLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Adriana De Siervi, PhD principal investigator
IBYME-CONICET
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, run by Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich 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 2 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 28 Feb 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 Adriana De Siervi, PhD (+54 911 3269-5832, adrianadesiervi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA levels in plasma (time frame: Day 1). 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 28 Feb 2024.