RecruitingNCT07046260
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)
Sponsor
Harbinger Health
Enrollment
1,650 participants
Start Date
Jul 11, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 45 Years
Inclusion Criteria5
- Subjects aged ≥45 years at the time of informed consent
- 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
- Presentation with symptoms, signs, and/or findings that raise clinical suspicion of one or more of the protocol-specified sites AND
- 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
- 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 Criteria8
- 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)
- Subject is suffering from any febrile illness defined as a temperature >101.5°F within 48 hours prior to blood draw
- Subject is pregnant (Self-reported)
- 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)
- Inability or unwillingness to comply with study procedures or follow-up requirement
- Previous or current participation in any study sponsored by, or employment with, Harbinger Health
- Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study
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Interventions
OTHERBlood sample collection
The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each participant.
Locations(39)
View Full Details on ClinicalTrials.gov
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NCT07046260
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