Prospective Study to Assess a Diagnostic Aid for Cancer

Summary

The primary objective of this study is to evaluate the performance of a blood-based diagnostic aid test for cancer detection in individuals presenting with symptoms, signs, or findings that raise clinical suspicion for cancer.

Eligibility

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 45 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 non-melanoma skin cancer are permitted)
2. Subject is suffering from any febrile illness defined as a temperature \>101.5°F within the last 48 hours
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

Conditions1

Locations34 sites

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