Breast NeoplasmNCT06672302
A Prospective Study to Develop and Clinically Validate an in Vitro Diagnostic Medical Device That Uses Blood to Classify Patients at High Risk for Breast Cancer
An observational study of Breast Neoplasm, run by EXoPERT at 3 sites in 2 countries.
Trial summary
EXoPERT has developed a liquid biopsy-based in vitro diagnostic medical device that can diagnose cancer through blood. The in vitro diagnostic medical device for this clinical performance trial is a test device that applies a technology that measures Raman spectroscopic signals of extracellular vesicles in the blood… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- ExoPred
- How many people
- 330 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Oct 2024to 31 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients categorized as BI-RADS category 4,5,6
Who may be able to join
- Korean nationality
- Voluntary written consent to participate in this clinical performance trial study
- Confirmed breast cancer through imaging/pathologic diagnostic tests
- Those who have been diagnosed with breast cancer at a stage prior to treatment and surgery, and who agree to participate in this study and are able to provide blood samples.
- Those whose lesions have been confirmed by conventional examination (breast ultrasound or mammography) and who fall into BI-RADS categories 4,5,6 and have undergone biopsy or are scheduled to undergo biopsy within 2 weeks.
- Those who meet the following demographic conditions A. Adult female, 40 years of age or older
Show all 14Show fewer
- Those who can provide the following clinical information A. Age and biological sex B. Whether or not they have dense breasts C. Occupational information D. Pathological tumor size, Clinical tumor size, Pathological TNM staging, Clinical TNM staging, tumor location, breast cancer histology findings (breast cancer subtype) E. Family history and past history of cancer F. Breast-related diseases G. Chronic disease history
- Korean nationality
- Voluntary written consent to participate in this clinical performance trial study
- Diagnosed with breast nodules through imaging/pathologic diagnostic tests
- Those who have been diagnosed with breast nodules and have agreed to participate in this study and are able to provide blood samples at a stage prior to treatment and surgery.
- Those whose lesions have been confirmed by conventional examination (breast ultrasound or mammography) and fall into BI-RADS categories 4,5,6 and have undergone biopsy or are scheduled for biopsy within 2 weeks
- Those who meet the following demographic conditions A. Adult female, 40 years of age or older
- Those who can provide the following clinical information A. Age and biological sex B. Whether or not they have dense breasts C. Occupational information D. Diagnosis, nodule size, and number of nodules E. Family history and past history of cancer F. Breast-related diseases G. Chronic disease history
Who cannot join
- Those who have been diagnosed with cancer (malignant tumor) of any type within 5 years of the date of consent and have undergone appropriate chemotherapy/radiation treatment or surgery.
- Those who are confirmed to have developed breast cancer due to metastasis from malignant tumors other than breast cancer
- Pregnant women
- Participation in a drug-related clinical trial within 3 months of the date of the informed consent form
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
South Korea2 sites, 2 recruiting
- Recruiting
Korea University Anam Hospital
Seoul
Dongwon You, +82-10-3062-8833, dwyou@exopert.com
Seungpil Jung, MD
- Recruiting
Korea University Guro Hospital
Seoul
Dongwon You, +82-10-3062-8833, dwyou@exopert.com
Wooyoung Kim, MD
United States1 site, 1 recruiting
- Not yet recruiting
Univercity of Hawaii Cancer Center
Honolulu, Hawaii, 96813
808-586-2979
About this study
Official title: A Multi-center, Single Arm, Prospective Exploratory in Vitro Diagnostic Devices Clinical Performance Study to Evaluate of in Vitro Diagnostic Devices for Auxiliary Diagnosis That Classifies High-risk and Low Risk Patients With Breast Cancer by Analyzing Surface-enhanced Raman Spectroscopy (SERS) Profiles of Extracellular Vesicles (EVs) Extracted From Human Plasma Using Artificial Intelligence
EXoPERT has developed a liquid biopsy-based in vitro diagnostic medical device that can diagnose cancer through blood. The in vitro diagnostic medical device for this clinical performance trial is a test device that applies a technology that measures Raman spectroscopic signals of extracellular vesicles in the blood and classifies high-risk and low-risk patients for breast cancer through artificial intelligence analysis.
The test device used in this clinical performance trial is expected to assist in the differential diagnosis of high-risk and low-risk breast cancer patients by developing a software algorithm for an in vitro diagnostic medical device for auxiliary diagnosis that classifies high-risk and low-risk breast cancer patients and confirming the clinical efficacy and safety of the device through this clinical performance trial.
Read the detailed description
According to the Korean Breast Cancer Society, when comparing the five-year survival rate of breast cancer patients by stage from 2001 to 2012, the survival rate is 98.3% for stage 0, 96.6% for stage 1, and 91.8% for stage 2, but the survival rate for stage 4 patients with systemic metastasis is 34%. Therefore, early detection and accurate diagnosis are very important for breast cancer treatment.
Currently, breast cancer is diagnosed through breast ultrasound and mammography. These imaging modalities are defined by the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) to define the specificity and various characteristics of the lesion. BI-RADS is divided into six categories: Category 1 is no abnormality, Category 2 is a definite benign tumor, Category 3 is a high likelihood of benign tumor (≤2% positive predictive value), Category 4 is a low likelihood of malignancy (≤2% positive predictive value), except for Category 0, which is an incomplete determination, Category 4 is a moderate suspicion of malignancy (2< positive predictive value <95%), Category 5 is a very high probability of malignancy (positive predictive value ≥95%), and Category 6 is a pathologically diagnosed malignancy.
In the Breast Imaging Reporting and Data System (BI-RADS), biopsy is not required in category 3 because the likelihood of malignancy is 2% or less, so a 6-month follow-up is recommended, and biopsy is recommended starting from category 4A, where the frequency of malignancy is 3 - 10%. However, the BI-RADS criteria have a significant number of false-positive results, which leads to an increase in unnecessary biopsies. The need for complementary diagnostic tests that can overcome the limitations of conventional imaging tests and compensate for unnecessary biopsies is being emphasized.
- Conditions
- Breast Neoplasm
- Being tested
- ExoPred
- Keywords
- Breast, Breast Cancer, Neoplasm
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoPredDiagnostic test
Performing in vitro diagnostics with devices developed by EXoPERT
| Study group | Role | What they receive |
|---|---|---|
| Breast malignant nodule group | Not described Receives: Diagnostic Test: ExoPred | |
| Breast benign nodule group | Not described Receives: Diagnostic Test: ExoPred |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Measured: through study completion, an average of 1 year
Specificity
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start16 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies 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
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EXoPERT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672302
- Sponsor's protocol ID
- EXP-B-P-2401
- Status last verified
- Jan 2026
- First submitted
- 31 Oct 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Song SE, Shin H, Park Y, Choi Y, Jung SP. Artificial Intelligence-Based Exosome Analysis for Improving Diagnostic Performance of Breast Lesions on Ultrasound: Protocol of a Prospective, Multicenter Cohort Study. J Breast Cancer. 2026 Apr;29(2):183-191. doi: 10.4048/jbc.2025.0206. Epub 2026 Apr 1.
PubMed 41918185
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single Arm, Prospective Exploratory in Vitro Diagnostic Devices Clinical Performance Study to Evaluate of in Vitro Diagnostic Devices for Auxiliary Diagnosis That Classifies High-risk and Low Risk Patients With Breast Cancer by Analyzing Surface-enhanced Raman Spectroscopy (SERS) Profiles of Extracellular Vesicles (EVs) Extracted From Human Plasma Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06672302
- Acronym / sponsor ID
- EXP-B-P-2401
- Conditions
- Breast Neoplasm
- Keywords
- Breast, Breast Cancer, Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- EXoPERTIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Nov 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.
EXoPERT has developed a liquid biopsy-based in vitro diagnostic medical device that can diagnose cancer through blood. The in vitro diagnostic medical device for this clinical performance trial is a test device that applies a technology that measures Raman spectroscopic signals of extracellular vesicles in the blood and classifies high-risk and low-risk patients for breast cancer through artificial intelligence analysis.
The test device used in this clinical performance trial is expected to assist in the differential diagnosis of high-risk and low-risk breast cancer patients by developing a software algorithm for an in vitro diagnostic medical device for auxiliary diagnosis that classifies high-risk and low-risk breast cancer patients and confirming the clinical efficacy and safety of the device through this clinical performance trial.
Detailed description
According to the Korean Breast Cancer Society, when comparing the five-year survival rate of breast cancer patients by stage from 2001 to 2012, the survival rate is 98.3% for stage 0, 96.6% for stage 1, and 91.8% for stage 2, but the survival rate for stage 4 patients with systemic metastasis is 34%. Therefore, early detection and accurate diagnosis are very important for breast cancer treatment.
Currently, breast cancer is diagnosed through breast ultrasound and mammography. These imaging modalities are defined by the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) to define the specificity and various characteristics of the lesion. BI-RADS is divided into six categories: Category 1 is no abnormality, Category 2 is a definite benign tumor, Category 3 is a high likelihood of benign tumor (≤2% positive predictive value), Category 4 is a low likelihood of malignancy (≤2% positive predictive value), except for Category 0, which is an incomplete determination, Category 4 is a moderate suspicion of malignancy (2< positive predictive value <95%), Category 5 is a very high probability of malignancy (positive predictive value ≥95%), and Category 6 is a pathologically diagnosed malignancy.
In the Breast Imaging Reporting and Data System (BI-RADS), biopsy is not required in category 3 because the likelihood of malignancy is 2% or less, so a 6-month follow-up is recommended, and biopsy is recommended starting from category 4A, where the frequency of malignancy is 3 - 10%. However, the BI-RADS criteria have a significant number of false-positive results, which leads to an increase in unnecessary biopsies. The need for complementary diagnostic tests that can overcome the limitations of conventional imaging tests and compensate for unnecessary biopsies is being emphasized.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast malignant nodule group | – | Diagnostic Test: ExoPred |
| Breast benign nodule group | – | Diagnostic Test: ExoPred |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients categorized as BI-RADS category 4,5,6
Key inclusion criteria (14 listed)
- Korean nationality
- Voluntary written consent to participate in this clinical performance trial study
- Confirmed breast cancer through imaging/pathologic diagnostic tests
- Those who have been diagnosed with breast cancer at a stage prior to treatment and surgery, and who agree to participate in this study and are able to provide blood samples.
- Those whose lesions have been confirmed by conventional examination (breast ultrasound or mammography) and who fall into BI-RADS categories 4,5,6 and have undergone biopsy or are scheduled to undergo biopsy within 2 weeks.
Key exclusion criteria (4 listed)
- Those who have been diagnosed with cancer (malignant tumor) of any type within 5 years of the date of consent and have undergone appropriate chemotherapy/radiation treatment or surgery.
- Those who are confirmed to have developed breast cancer due to metastasis from malignant tumors other than breast cancer
- Pregnant women
- Participation in a drug-related clinical trial within 3 months of the date of the informed consent form
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 |
|---|---|---|
| ExoPredPerforming in vitro diagnostics with devices developed by EXoPERT | Diagnostic test | Breast benign nodule group, Breast malignant nodule group |
Primary outcome
Sensitivity
Time frame: through study completion, an average of 1 year
Specificity
Time frame: through study completion, an average of 1 year
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 10 Sep 2026.
- Derived from this study: PubMed 41918185Song SE, Shin H, Park Y, Choi Y, Jung SP. Artificial Intelligence-Based Exosome Analysis for Improving Diagnostic Performance of Breast Lesions on Ultrasound: Protocol of a Prospective, Multicenter Cohort Study. J Breast Cancer. 2026 Apr;29(2):183-191. doi: 10.4048/jbc.2025.0206. Epub 2026 Apr 1.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Neoplasm
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm, run by EXoPERT at 3 sites in 2 countries.
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 14 inclusion and 4 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea, United States. 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 Jongwon Choi (+82-10-3931-2941, necain1003@exopert.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06672302, which also lists 1 linked publication.
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 10 Sep 2026.