Prospective Study to Assess a Diagnostic Aid for Cancer

Prospective Cohort Study With Case Enrichment to Assess a Diagnostic Aid for Cancer in Symptomatic Subjects (PROCARES)

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.

Inclusion Criteria:

1. Subjects aged ≥45 years at the time of informed consent

2. Provided written or electronic informed consent, according to local guidelines, signed and dated by the Subject or by a legal guardian prior to the performance of any study- specific procedures, sampling, or analyses

3. Presentation with symptoms, signs, and/or findings that raise clinical suspicion of one or more of the protocol-specified sites AND

   1. undergoing diagnostic work-up to determine if cancer is present, but do not yet have a confirmed cancer diagnosis. Subject must be willing to undergo a standard diagnostic work-up per local SoC to establish clinical truth regarding the presence or absence of cancer OR
   2. have a confirmed diagnosis of cancer, determined within 90 days prior to signing the Informed Consent Form, based on standard diagnostic procedures (histopathology, imaging, etc.) following presentation with symptoms, signs, and/or findings that raised a clinical suspicion of one or more cancers originating from the protocol-specified sites. Must be treatment-naïve for the diagnosed cancer at the time of enrollment.

Exclusion Criteria:

1. History of any prior invasive or hematological malignancy (Individuals with completely resected ductal carcinoma in-situ or completely resected non-melanoma skin cancer are permitted)
2. Subject is suffering from any febrile illness defined as a temperature >101.5°F within 48 hours prior to blood draw
3. Subject is pregnant (Self-reported)
4. Subject is a recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Subject with a corneal transplant can be considered for study entry)
5. Inability or unwillingness to comply with study procedures or follow-up requirement
6. Previous or current participation in any study sponsored by, or employment with, Harbinger Health
7. Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study