Breast CancerNCT07186296
EXoPERT EMERALD Clinical Study
An observational study of Breast Cancer and Colon Cancer, run by EXoPERT at 9 sites in United States.
Trial summary
The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colon Cancer, Pancreatic Cancer
- What is being tested?
- EXoPred
- How many people
- 1,400 participants
- Where
- 9 sitesUnited States
- Study dates
- 9 May 2025to 31 Aug 2026
- How long will I take part?
- 1 Day
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be collected from hospitals/clinical care settings with access to the intended population.
Who may be able to join
- Subject aged 45 years or older with a biopsy-proven or clinically suspected primary lung, breast, colorectal, pancreatic, or ovarian cancer, based on objective findings such as radiological, serological, endoscopic, or cytological findings, whose blood was collected prior to any systemic or definitive therapy for the cancer.
- Subjects who are willing and able to provide written informed consent.
- Subjects who are willing and able to comply with the study requirements.
Who cannot join
- Any history of cancer diagnosed and treated within 5 years prior to the date of consent.
- Subjects with a history of previous cancer treatment via surgical resection, hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months for recent cancer diagnosis.
- Subjects who have any history of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.
- Subjects who are pregnant or breastfeeding women.
- Subjects who have consented and have undergone treatment in any other cancer related clinical trials withinthe past 6 months.
- Subjects who are currently in active treatment for drug abuse.
- Subjects who have received any treatment related to lung, breast, colorectal, pancreatic, or ovarian nodules, such as hormones prior to entering the study.
- Unsuitable sample for testing due to contamination, hemolysis, etc.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Albany Stratton VA Medical Center
Albany, New York, 12208
Jennifer Thomson, MA, (518) 915-4286, jennifer.thomson@va.gov
Maithao Le, MD, PhD, FACS
- Recruiting
John Hopkins University
Baltimore, Maryland, 21218
Jonathan Dudley, M.D., 410-955-5000, jdudley5@jh.edu
Jonathan Dudley, MD
- Recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Shawn Iwata, RN, 808-564-3992, siwata@cc.hawaii.edu
Elizabeth Nakasone, MD, PhD
- Recruiting
Lexington VA Healthcare System
Lexington, Kentucky, 40502
Rebekah Evans, RN, BSN, CCRP, 859-233-4511 ext. 5223, Rebekah.evans1@va.gov
Mouna Abouamara, MD
- Recruiting
Tibor Rubin VA Medical Center
Long Beach, California, 90822
Neha Shah, PhD, CCRP, 562-826-8000 ext. 13284, Neha.Shah3@va.gov
Pankaj Gupta, MD
- Recruiting
City of Hope Duarte Cancer Center
Los Angeles, California, 91010
Angelica Hamilton, 626-218-0109, ahamilton@coh.org
Jae Kim, MD
- Recruiting
KCTL
Louisville, Kentucky, 40202
Yenny Lamazares, 502-569-0337, ylamazares@kentuckyctl.com
Saeed Jortani, Ph.D.
- Recruiting
Bronx Veterans Medical Research Foundation
The Bronx, New York, 10468
Serena Yeung, 718-584-9000 ext. 1809, serena.yeung@va.gov
Yeun-Hee Park, MD
- Recruiting
VA Hudson Valley Healthcare System
Wappingers Falls, New York, 12590
Serena Yeung, 718-584-9000 ext. 1809, serena.yeung@va.gov
Christina Sportiello, Christina.Sportiello@va.gov
About this study
Official title: EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol
The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software. The software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) extracted from human plasma for the early detection of multiple cancers, including lung, ovarian, breast, pancreatic, and colorectal cancers.
Read the detailed description
The EMERALD study is a multi-center study (Protocol No. EXPT-MC-F-2024) designed to establish a clinical plasma repository for the training and clinical evaluation of the ExoPred deep learning software
The study protocol operates in three sequential phases to ensure data integrity and prevent algorithmic overfitting:
Phase 1 (Algorithm Training Stage): A minimum of 500 samples are analyzed to develop the algorithm and establish the initial clinical cut-off values, followed by a database lock.
Phase 2 (Algorithm Lock-Readiness Assessment): A minimum of 50 newly acquired unknown samples are evaluated to assess model robustness before the final algorithm is formally locked in the Technical File.
Phase 3 (Blinded Independent Stage): A minimum of 200 independent samples, strictly excluded from prior phases, are tested under strict blinding to evaluate finalized clinical sensitivity, specificity, and accuracy.
The locked software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) to detect five target malignancies: lung, breast, colorectal, pancreatic, and ovarian cancers. Based on multi-class classification probability scoring, the predicted tissue of origin (TOO) can be presented for up to a maximum of three cancer types. All data handling and automated quality checks follow standard operating procedures (SOPs) within a 21 CFR Part 11 compliant EDC system.
- Conditions
- Breast Cancer, Colon Cancer, Pancreatic Cancer, Ovarian Cancer, Lung Cancer
- Being tested
- EXoPred
- Keywords
- Early-stage, In vitro Diagnostic Test, Artificial intelligence, extracellular vesicles, multi cancer diagnosis, cancer
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXoPredDiagnostic test
Performing invitro Diagnostics with devices developed by EXoPERT.
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described Receives: Diagnostic Test: EXoPred | |
| Lung Cancer | Not described Receives: Diagnostic Test: EXoPred | |
| Breast Cancer | Not described Receives: Diagnostic Test: EXoPred | |
| Colorectal Cancer | Not described Receives: Diagnostic Test: EXoPred | |
| Pancreatic Cancer | Not described Receives: Diagnostic Test: EXoPred | |
| Ovarian Cancer | Not described Receives: Diagnostic Test: EXoPred |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Sufficient Samples
Test sufficient samples from 5 cancers to lock an validate algorithm to support future clinical study.
Measured: From date of enrollment up to 36 months
Evaluate Performance
Test performance: diagnosis of multiple cancer, assessed by sensitivity. Test performance: diagnosis of multiple cancer, assessed by specificity. Test performance: diagnosis of multiple cancer, assessed by tissue of origin (TOO) accuracy.
Measured: From date of enrollment up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start9 May 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (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
- Case-control
- Time perspective
- Other
- Enrolment
- 1,400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- EXoPERT
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Jonathan Dudley, MD, Principal investigator, Johns Hopkins UniversitySaeed Jortani, Ph.D., Principal investigator, Kentucky Clinical Trial Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186296
- Sponsor's protocol ID
- EXPT-MC-F-2024
- Status last verified
- Jun 2026
- First submitted
- 29 Aug 2025
- Last updated
- 1 Jul 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT07186296
- Acronym / sponsor ID
- EXPT-MC-F-2024
- Conditions
- Breast Cancer, Colon Cancer, Pancreatic Cancer, Ovarian Cancer, Lung Cancer
- Keywords
- Early-stage, In vitro Diagnostic Test, Artificial intelligence, extracellular vesicles, multi cancer diagnosis, cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- EXoPERTIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 9 May 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 Sep 2025 (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.
The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software. The software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) extracted from human plasma for the early detection of multiple cancers, including lung, ovarian, breast, pancreatic, and colorectal cancers.
Detailed description
The EMERALD study is a multi-center study (Protocol No. EXPT-MC-F-2024) designed to establish a clinical plasma repository for the training and clinical evaluation of the ExoPred deep learning software
The study protocol operates in three sequential phases to ensure data integrity and prevent algorithmic overfitting:
Phase 1 (Algorithm Training Stage): A minimum of 500 samples are analyzed to develop the algorithm and establish the initial clinical cut-off values, followed by a database lock.
Phase 2 (Algorithm Lock-Readiness Assessment): A minimum of 50 newly acquired unknown samples are evaluated to assess model robustness before the final algorithm is formally locked in the Technical File.
Phase 3 (Blinded Independent Stage): A minimum of 200 independent samples, strictly excluded from prior phases, are tested under strict blinding to evaluate finalized clinical sensitivity, specificity, and accuracy.
The locked software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) to detect five target malignancies: lung, breast, colorectal, pancreatic, and ovarian cancers. Based on multi-class classification probability scoring, the predicted tissue of origin (TOO) can be presented for up to a maximum of three cancer types. All data handling and automated quality checks follow standard operating procedures (SOPs) within a 21 CFR Part 11 compliant EDC system.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: EXoPred |
| Lung Cancer | – | Diagnostic Test: EXoPred |
| Breast Cancer | – | Diagnostic Test: EXoPred |
| Colorectal Cancer | – | Diagnostic Test: EXoPred |
| Pancreatic Cancer | – | Diagnostic Test: EXoPred |
| Ovarian Cancer | – | Diagnostic Test: EXoPred |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be collected from hospitals/clinical care settings with access to the intended population.
Key inclusion criteria (3 listed)
- Subject aged 45 years or older with a biopsy-proven or clinically suspected primary lung, breast, colorectal, pancreatic, or ovarian cancer, based on objective findings such as radiological, serological, endoscopic, or cytological findings, whose blood was collected prior to any systemic or definitive therapy for the cancer.
- Subjects who are willing and able to provide written informed consent.
- Subjects who are willing and able to comply with the study requirements.
Key exclusion criteria (8 listed)
- Any history of cancer diagnosed and treated within 5 years prior to the date of consent.
- Subjects with a history of previous cancer treatment via surgical resection, hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months for recent cancer diagnosis.
- Subjects who have any history of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.
- Subjects who are pregnant or breastfeeding women.
- Subjects who have consented and have undergone treatment in any other cancer related clinical trials withinthe past 6 months.
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 invitro Diagnostics with devices developed by EXoPERT. | Diagnostic test | Breast Cancer, Colorectal Cancer, Control, Lung Cancer, Ovarian Cancer, Pancreatic Cancer |
Primary outcome
Test Sufficient Samples
Time frame: From date of enrollment up to 36 months
Test sufficient samples from 5 cancers to lock an validate algorithm to support future clinical study.
Evaluate Performance
Time frame: From date of enrollment up to 36 months
Test performance: diagnosis of multiple cancer, assessed by sensitivity. Test performance: diagnosis of multiple cancer, assessed by specificity. Test performance: diagnosis of multiple cancer, assessed by tissue of origin (TOO) accuracy.
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 1 Jul 2026.
- 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.
Jonathan Dudley, MD principal investigator
Johns Hopkins University
Saeed Jortani, Ph.D. principal investigator
Kentucky Clinical Trial Laboratory
9 sites 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 and Colon Cancer, run by EXoPERT at 9 sites in United States.
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 3 inclusion and 8 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in 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 Young Park ((+82) 02 923 8833, paark76@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Sufficient Samples (time frame: From date of enrollment up to 36 months). 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?
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 1 Jul 2026.