What this study is
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.
What's being tested
- EXoPred
Intervention · DIAGNOSTIC TEST
Performing invitro Diagnostics with devices developed by EXoPERT.
Study details
- Official title
- EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol
- Sponsor
- EXoPERT
- Conditions
- Breast Cancer · Colon Cancer · Pancreatic Cancer · Ovarian Cancer · Lung Cancer
- Enrolling
- 1,400 people
- Starts
- 2025-05-09
- Est. completion
- 2026-08-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (9)
9 openTibor Rubin VA Medical Center
Long Beach, California, United States
- Neha Shah, PhD, CCRP · Contact562-826-8000 ext. 13284Neha.Shah3@va.gov
- Pankaj Gupta, MD · Principal investigator
RecruitingCity of Hope Duarte Cancer Center
Los Angeles, California, United States
- Angelica Hamilton · Contact626-218-0109ahamilton@coh.org
- Jae Kim, MD · Principal investigator
RecruitingUniversity of Hawaii Cancer Center
Honolulu, Hawaii, United States
- Shawn Iwata, RN · Contact808-564-3992siwata@cc.hawaii.edu
- Elizabeth Nakasone, MD, PhD · Principal investigator
RecruitingLexington VA Healthcare System
Lexington, Kentucky, United States
- Rebekah Evans, RN, BSN, CCRP · Contact859-233-4511 ext. 5223Rebekah.evans1@va.gov
- Mouna Abouamara, MD · Principal investigator
RecruitingKCTL
Louisville, Kentucky, United States
- Yenny Lamazares · Contact502-569-0337ylamazares@kentuckyctl.com
- Saeed Jortani, Ph.D. · Principal investigator
RecruitingJohn Hopkins University
Baltimore, Maryland, United States
- Jonathan Dudley, M.D. · Contact410-955-5000jdudley5@jh.edu
- Jonathan Dudley, MD · Principal investigator
RecruitingAlbany Stratton VA Medical Center
Albany, New York, United States
- Jennifer Thomson, MA · Contact(518) 915-4286jennifer.thomson@va.gov
- Maithao Le, MD, PhD, FACS · Principal investigator
RecruitingBronx Veterans Medical Research Foundation
The Bronx, New York, United States
- Serena Yeung · Contact718-584-9000 ext. 1809serena.yeung@va.gov
- Yeun-Hee Park, MD · Principal investigator
RecruitingVA Hudson Valley Healthcare System
Wappingers Falls, New York, United States
- Serena Yeung · Contact718-584-9000 ext. 1809serena.yeung@va.gov
- Christina Sportiello · ContactChristina.Sportiello@va.gov
- Ponciano Reyes, MD · Principal investigator
Recruiting
Study team
Sponsor
EXoPERT
Study ID EXPT-MC-F-2024
Principal investigator
Jonathan Dudley, MD
Johns Hopkins University
Principal investigator
Saeed Jortani, Ph.D.
Kentucky Clinical Trial Laboratory
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.