EXoPERT EMERALD Clinical Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorEXoPERT
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
This trial accepts healthy volunteersQualifiers
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 population
Study participants will be collected from hospitals/clinical care settings with access to the intended population.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
EXoPred
Diagnostic testPerforming invitro Diagnostics with devices developed by EXoPERT.
Treatment groups
1,400 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Control1 intervention
Group B: Lung Cancer1 intervention
Group C: Breast Cancer1 intervention
Group D: Colorectal Cancer1 intervention
Group E: Pancreatic Cancer1 intervention
Group F: Ovarian Cancer1 intervention
Trial outcomes
Primary outcomes
1
Test Sufficient Samples
Test sufficient samples from 5 cancers to lock an validate algorithm to support future clinical study.
Time frame
From date of enrollment up to 36 months2
Evaluate Performance
Test performance: diagnosis of multiple cancer, assessed by sensitivity. Test performance: diagnosis of multiple cancer, assessed by specificity. Test performance: diagnosis of multiple cancer, assessed by tissue of origin (TOO) accuracy.
Time frame
From date of enrollment up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
EXoPERT
Lead sponsor
MCRA
Collaborator
Source ClinicalTrials.gov