RECRUITING

EXoPERT EMERALD Clinical Study

Conditions

Breast Cancer Colon Cancer Pancreatic Cancer Ovarian Cancer Lung Cancer Early-stage In vitro Diagnostic Test Artificial intelligence extracellular vesicles multi cancer diagnosis cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-09

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07186296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects aged 45 years or older with a biopsy-proven lung, breast, colorectal, pancreatic, or ovarian cancer, as their primary cancer, but 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.	* 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 hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months. * Subjects who have evidence of active febrile infection prior to blood draw. * Subjects who have any history of an allogeneic bone marrow, stem cell transplant, or solid organ transplant. * Subjects who have been diagnosed with dementia or neurological disease. * Subjects who are pregnant or breastfeeding women. * Subjects who have consented and have undergone treatment in any other clinical trials within the 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.

Inclusion Criteria

Exclusion Criteria

* Subjects aged 45 years or older with a biopsy-proven lung, breast, colorectal, pancreatic, or ovarian cancer, as their primary cancer, but 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.

* 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 hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months.
* Subjects who have evidence of active febrile infection prior to blood draw.
* Subjects who have any history of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.
* Subjects who have been diagnosed with dementia or neurological disease.
* Subjects who are pregnant or breastfeeding women.
* Subjects who have consented and have undergone treatment in any other clinical trials within the 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.

Contacts and Locations

Study Contact

Young Park

CONTACT

(+82) 02 923 8833

paark76@korea.ac.kr

Yeonho Choi

CONTACT

(+82) 02 923 8833

yeonhochoi@exopert.com

Principal Investigator

Jonathan Dudley, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Saeed Jortani, Ph.D.

PRINCIPAL_INVESTIGATOR

Kentucky Clinical Trial Laboratory

Study Locations (Sites)

KCTL

Louisville, Kentucky, 40202

United States

John Hopkins University

Baltimore, Maryland, 21218

United States

Collaborators and Investigators

Sponsor: EXoPERT

Jonathan Dudley, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
Saeed Jortani, Ph.D., PRINCIPAL_INVESTIGATOR, Kentucky Clinical Trial Laboratory

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-09

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-05-09

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Breast Cancer
Colon Cancer
Pancreatic Cancer
Ovarian Cancer
Lung Cancer