Overview
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.
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.
Eligibility
Inclusion 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.
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 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.