EXoPERT EMERALD Clinical Study

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

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.

Conditions6

Locations9 sites

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