EXoPERT EMERALD Clinical Study

Last updated: January 18, 2026
Sponsor: EXoPERT
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Non-small Cell Lung Cancer

Colon Cancer

Treatment

EXoPred

Clinical Study ID

NCT07186296
EXPT-MC-F-2024
  • Ages > 45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject aged 45 years or older with a biopsy-proven or clinically suspected primarylung, breast, colorectal, pancreatic, or ovarian cancer, based on objective findingssuch as radiological, serological, endoscopic, or cytological findings, whose bloodwas 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

Exclusion Criteria:

  • Any history of cancer diagnosed and treated within 5 years prior to the date ofconsent.

  • Subjects with a history of previous cancer treatment via surgical resection,hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months forrecent cancer diagnosis.

  • Subjects who have any history of an allogeneic bone marrow, stem cell transplant, orsolid organ transplant.

  • Subjects who are pregnant or breastfeeding women.

  • Subjects who have consented and have undergone treatment in any other cancer relatedclinical 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

Total Participants: 1400
Treatment Group(s): 1
Primary Treatment: EXoPred
Phase:
Study Start date:
May 09, 2025
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Tibor Rubin VA Medical Center

    Long Beach 5367929, California 5332921 90822
    United States

    Active - Recruiting

  • City of Hope Duarte Cancer Center

    Los Angeles 5368361, California 5332921 91010
    United States

    Active - Recruiting

  • University of Hawaii Cancer Center

    Honolulu 5856195, Hawaii 5855797 96813
    United States

    Site Not Available

  • Lexington VA Healthcare System

    Lexington 4297983, Kentucky 6254925 40502
    United States

    Active - Recruiting

  • KCTL

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

  • John Hopkins University

    Baltimore 4347778, Maryland 4361885 21218
    United States

    Site Not Available

  • Albany Stratton VA Medical Center

    Albany 5106834, New York 5128638 12208
    United States

    Active - Recruiting

  • Bronx Veterans Medical Research Foundation

    The Bronx 5110266, New York 5128638 10468
    United States

    Site Not Available

  • VA Hudson Valley Healthcare System

    Wappingers Falls 5143211, New York 5128638 12590
    United States

    Site Not Available

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