EXoPERT EMERALD Clinical Study

EXoPERT

Status

Enrolling

Conditions

Breast Cancer

Colon Cancer

Lung Cancer

Ovarian Cancer

Pancreatic Cancer

Treatments

Diagnostic Test: EXoPred

Study type

Observational

Funder types

Industry

Identifiers

NCT07186296

EXPT-MC-F-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,400 estimated patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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.