Recruiting

Diagnostic TestEXoPERT EMERALD Clinical Study

Sponsor:

EXoPERT

Code:

NCT07186296

Conditions

Breast Cancer

Colon Cancer

Pancreatic Cancer

Ovarian Cancer

Lung Cancer

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

Interventions

EXoPred

Study Details

Brief 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. 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.

Conditions

Breast Cancer

Colon Cancer

Pancreatic Cancer

Ovarian Cancer

Lung Cancer

Study ID

NCT07186296

Start date

May 9, 2025

Status verified date

Jun, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1400 participants

Anticipated

Interventions and Outcome Measures

Arms

Control

Lung Cancer

Breast Cancer

Colorectal Cancer

Pancreatic Cancer

Ovarian Cancer

Interventions

EXoPred

Performing invitro Diagnostics with devices developed by EXoPERT.

Primary outcome measure

Test Sufficient Samples [ Time Frame: From date of enrollment up to 36 months ]
Evaluate Performance [ Time Frame: From date of enrollment up to 36 months ]

Central Contacts and Locations

Central contacts

Young Park

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

Yeonho Choi

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

Locations

Tibor Rubin VA Medical Center

Recruiting

Long Beach, California, United States, 90822

Contacts

Neha Shah, PhD, CCRP

562-826-8000 Neha.Shah3@va.gov

Principal Investigator:

Pankaj Gupta, MD

City of Hope Duarte Cancer Center

Recruiting

Los Angeles, California, United States, 91010

Contacts

Angelica Hamilton

626-218-0109 ahamilton@coh.org

Principal Investigator:

Jae Kim, MD

University of Hawaii Cancer Center

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Shawn Iwata, RN

808-564-3992 siwata@cc.hawaii.edu

Principal Investigator:

Elizabeth Nakasone, MD, PhD

Lexington VA Healthcare System

Recruiting

Lexington, Kentucky, United States, 40502

Contacts

Rebekah Evans, RN, BSN, CCRP

859-233-4511 Rebekah.evans1@va.gov

Principal Investigator:

Mouna Abouamara, MD

KCTL

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Yenny Lamazares

502-569-0337 ylamazares@kentuckyctl.com

Principal Investigator:

Saeed Jortani, Ph.D.

John Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Jonathan Dudley, M.D.

410-955-5000 jdudley5@jh.edu

Principal Investigator:

Jonathan Dudley, MD

Albany Stratton VA Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Jennifer Thomson, MA

(518) 915-4286 jennifer.thomson@va.gov

Principal Investigator:

Maithao Le, MD, PhD, FACS

Bronx Veterans Medical Research Foundation

Recruiting

The Bronx, New York, United States, 10468

Contacts

Serena Yeung

718-584-9000 serena.yeung@va.gov

Principal Investigator:

Yeun-Hee Park, MD

VA Hudson Valley Healthcare System

Recruiting

Wappingers Falls, New York, United States, 12590

Contacts

Serena Yeung

718-584-9000 serena.yeung@va.gov

Christina Sportiello

Christina.Sportiello@va.gov

Principal Investigator:

Ponciano Reyes, MD

More Information

Sponsor

EXoPERT

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

Early-stage
In vitro Diagnostic Test
Artificial intelligence
extracellular vesicles
multi cancer diagnosis
cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by EXoPERT on 2026-07-01.