Health Trials

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • EXoPred

Treatment groups

1,400 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

9
Tibor Rubin VA Medical Center90822, Long BeachCalifornia, United States
City of Hope Duarte Cancer Center91010, Los AngelesCalifornia, United States
University of Hawaii Cancer Center96813, HonoluluHawaii, United States
Lexington VA Healthcare System40502, LexingtonKentucky, United States

Sponsors and collaborators

EXoPERT

Lead sponsor

MCRA

Collaborator

Source ClinicalTrials.gov