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EXoPERT EMERALD Clinical Study | Clinical Trials | Clareo Health

RECRUITING

EXoPERT EMERALD Clinical Study

EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol

NCT07186296•EXoPERT

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.

Detailed Description

An in vitro diagnostic medical device and system that provides information on the presence of lung, ovarian, breast, pancreas and colorectal cancers based on a deep learning analysis for Raman spectroscopic profiles of EV's extracted from human plasma. Tissue of origin (TOO) can be presented as one or more.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (9)

Tibor Rubin VA Medical Center

Long Beach, California, United States

City of Hope Duarte Cancer Center

Los Angeles, California, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Lexington VA Healthcare System

Lexington, Kentucky, United States

KCTL

Louisville, Kentucky, United States

John Hopkins University

Baltimore, Maryland, United States

Albany Stratton VA Medical Center

Albany, New York, United States

Bronx Veterans Medical Research Foundation

The Bronx, New York, United States

VA Hudson Valley Healthcare System

Wappingers Falls, New York, United States

Key Dates

Start Date

May 9, 2025

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2026

Last Updated

January 21, 2026

Enrollment

1,400

ESTIMATED participants

Conditions

Breast CancerColon CancerPancreatic CancerOvarian CancerLung Cancer

Interventions

EXoPred

DIAGNOSTIC_TEST

Contacts

Young Park

CONTACT

(+82) 02 923 8833 paark76@korea.ac.kr

Yeonho Choi

CONTACT

(+82) 02 923 8833 yeonhochoi@exopert.com

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

EXoPERT EMERALD Clinical Study

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors