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Recruiting Observational

EXoPERT EMERALD Clinical Study

NCT07186296 · tracked via the Priya Life Science USA tracker
Sponsor
EXoPERT
Phase
Observational
Started
2025-05-09
Last updated
2026-07-01

Condition(s) studied

Breast CancerColon CancerPancreatic CancerOvarian CancerLung Cancer

Investigational drug(s) / intervention(s)

EXoPred

EXoPred: Performing invitro Diagnostics with devices developed by EXoPERT.

Study 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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
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.

Primary outcome measure(s)

  • Test Sufficient Samples — 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 — 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.

Trial sites (9)

FacilityCityRegionStatus
Tibor Rubin VA Medical Center Long Beach California Recruiting
City of Hope Duarte Cancer Center Los Angeles California Recruiting
University of Hawaii Cancer Center Honolulu Hawaii Recruiting
Lexington VA Healthcare System Lexington Kentucky Recruiting
KCTL Louisville Kentucky Recruiting
John Hopkins University Baltimore Maryland Recruiting
Albany Stratton VA Medical Center Albany New York Recruiting
Bronx Veterans Medical Research Foundation The Bronx New York Recruiting
VA Hudson Valley Healthcare System Wappingers Falls New York Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07186296 on ClinicalTrials.gov ↗ ← All trials in the USA