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

NCT ID: NCT07186296Sponsor: EXoPERTLast updated: 2026-01-21

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.

Arms & interventions

  • Diagnostic TestEXoPred

    Performing invitro Diagnostics with devices developed by EXoPERT.

Outcome measures

Primary

  • Test Sufficient Samples

    Test sufficient samples from 5 cancers to lock an validate algorithm to support future clinical study.

    Time frame: 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.

    Time frame: From date of enrollment up to 36 months

Eligibility criteria

Sex: AllAge: 45 Years and olderHealthy 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.

Study locations (9)

Tibor Rubin VA Medical Center

Long Beach, California, 90822

Recruiting
Neha Shah, PhD, CCRP · Contact
Pankaj Gupta, MD · Principal Investigator

City of Hope Duarte Cancer Center

Los Angeles, California, 91010

Recruiting
Angelica Hamilton · Contact
Jae Kim, MD · Principal Investigator

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813

Not Yet Recruiting
Shawn Iwata, RN · Contact
Elizabeth Nakasone, MD, PhD · Principal Investigator

Lexington VA Healthcare System

Lexington, Kentucky, 40502

Recruiting
Rebekah Evans, RN, BSN, CCRP · Contact
Mouna Abouamara, MD · Principal Investigator

KCTL

Louisville, Kentucky, 40202

Recruiting
Yenny Lamazares · Contact
Saeed Jortani, Ph.D. · Principal Investigator

John Hopkins University

Baltimore, Maryland, 21218

Active Not Recruiting

Albany Stratton VA Medical Center

Albany, New York, 12208

Recruiting
Jennifer Thomson, MA · Contact
Maithao Le, MD, PhD, FACS · Principal Investigator

Bronx Veterans Medical Research Foundation

The Bronx, New York, 10468

Not Yet Recruiting
Serena Yeung · Contact
Yeun-Hee Park, MD · Principal Investigator

VA Hudson Valley Healthcare System

Wappingers Falls, New York, 12590

Not Yet Recruiting
Serena Yeung · Contact
Christina Sportiello · Contact
Ponciano Reyes, MD · Principal Investigator
EXoPERT EMERALD Clinical Study | Cancerify