| NCT ID | NCT07186296 |
| Status | Recruiting |
| Phase | — |
| Sponsor | EXoPERT |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2025-05-09 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,400 participants in total. It began in 2025-05-09 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Jonathan Dudley, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07186296 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07186296 currently recruiting?
Yes, NCT07186296 is actively recruiting participants. Contact the research team at paark76@korea.ac.kr for enrollment information.
Where is the NCT07186296 trial being conducted?
This trial is being conducted at Long Beach, United States, Los Angeles, United States, Honolulu, United States, Lexington, United States and 5 additional locations.
Who is sponsoring the NCT07186296 clinical trial?
NCT07186296 is sponsored by EXoPERT. The principal investigator is Jonathan Dudley, MD at Johns Hopkins University. The trial plans to enroll 1,400 participants.
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