The primary objective of this study is to establish the performance of two blood-based diagnostic aid test for cancer detection in individuals presenting with symptoms, signs, or findings suggestive of cancer.
Subjects 45 years of age and older presenting with symptoms, signs, and/or findings suggestive of one or more cancers originating from protocol-specified sites will be enrolled. Subjects will complete a blood draw for analysis by the investigational diagnostic aid test. For subjects with suspected cancer at enrollment, clinical outcomes will be determined following completion of a standard-of-care diagnostic work-up as clinically indicated. Subjects with a confirmed cancer diagnosis at enrollment must be treatment-naïve and will have diagnosis details collected at the time of enrollment. The results of the investigational diagnostic aid test will not be provided to investigators, treating clinicians, or subjects. Personnel performing clinical evaluations, determining final diagnoses, or reviewing diagnostic imaging and pathology reports will remain blinded to the results of the investigational test. All testing and associated analyses will be conducted in a blinded fashion, and test results will not inform clinical decision-making.
Study Type
OBSERVATIONAL
Enrollment
1,650
The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each participant.
Performance of two diagnostic aid tests among individuals presenting with symptoms, signs and/or clinical findings suggestive of one or more cancers originating from the protocol-specified sites: a multi-cancer (MC) and gastrointestinal-focused (GI) test
* Predictive value of the Harbinger multi-cancer (MC) test by each readout category. * Predictive value of the Harbinger GI test by each readout category.
Time frame: 18 months
Quantify test readout distribution, likelihood ratio, and marginal classification distribution of each Harbinger test
* Establish for each Harbinger test the classification distributions for non-cancer individuals, and for cancer cases overall and by early-stage (I and II) and late-stage (III and IV) and further by cancer type. * Establish for each Harbinger test the likelihood ratio for each readout category, overall, by cancer stage and further by cancer type. * Establish for each Harbinger test the classification category frequency distribution.
Time frame: 18 months
Establish cancer incidence in this intended use population
-Establish the cancer incidence, overall and by early-stage (I and II) and late-stage (III and IV) and further by cancer type.
Time frame: 18 months
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