EXoPERT EMERALD Clinical Study
EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol
1 other identifier
observational
1,400
1 country
9
Brief Summary
Invitro diagnostic test for multiple cancer diagnosis for patients with early-stage cancers by analyzing surface-enhanced Ramen spectroscopy (SERS) profiles of extracellular vesicles (EV) using artificial intelligence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2025
CompletedFirst Submitted
Initial submission to the registry
August 29, 2025
CompletedFirst Posted
Study publicly available on registry
September 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
January 21, 2026
September 1, 2025
1.1 years
August 29, 2025
January 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Test Sufficient Samples
Test sufficient samples from 5 cancers to lock an validate algorithm to support future clinical study.
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.
From date of enrollment up to 36 months
Study Arms (6)
Control
Lung Cancer
Breast Cancer
Colorectal Cancer
Pancreatic Cancer
Ovarian Cancer
Interventions
Performing invitro Diagnostics with devices developed by EXoPERT.
Eligibility Criteria
Study participants will be collected from hospitals/clinical care settings with access to the intended population.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Tibor Rubin VA Medical Center
Long Beach, California, 90822, United States
City of Hope Duarte Cancer Center
Los Angeles, California, 91010, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Lexington VA Healthcare System
Lexington, Kentucky, 40502, United States
KCTL
Louisville, Kentucky, 40202, United States
John Hopkins University
Baltimore, Maryland, 21218, United States
Albany Stratton VA Medical Center
Albany, New York, 12208, United States
Bronx Veterans Medical Research Foundation
The Bronx, New York, 10468, United States
VA Hudson Valley Healthcare System
Wappingers Falls, New York, 12590, United States
Biospecimen
Prospective with frozen plasma aliquots being retained. Frozen exosomes are also being stored after testing.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Dudley, MD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Saeed Jortani, Ph.D.
Kentucky Clinical Trial Laboratory
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2025
First Posted
September 22, 2025
Study Start
May 9, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
January 21, 2026
Record last verified: 2025-09