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Two blood-based tests to help detect cancer in adults with possible cancer symptoms

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

Observational Harbinger Health · NCT07046260

This program will test two blood-based diagnostics to see if they can detect cancer in adults 45 and older who have symptoms, signs, or findings that might be cancer.

Quick facts

Study typeObservational
Enrollment1650 (estimated)
Ages45 Years and up
SexAll
SponsorHarbinger Health Industry-sponsored
Locations39 sites (Coronado, California and 38 other locations)
Trial IDNCT07046260 on ClinicalTrials.gov

What this trial studies

Adults aged 45 and older who present with symptoms, signs, or findings that raise suspicion for cancers at protocol-specified sites will give a blood sample for two investigational diagnostic tests. Some participants will be undergoing diagnostic work-up to determine whether cancer is present, and others may have a recent, treatment-naïve confirmed diagnosis. All blood testing and analyses will be performed blinded, and results will not be shared with clinicians or patients or used to guide care. Final clinical diagnoses will be determined from standard-of-care diagnostic work-ups, imaging, and pathology as applicable.

Who should consider this trial

Good fit: Adults aged 45 years or older who have symptoms, signs, or findings that raise clinical suspicion for one or more protocol-specified cancers and who are either undergoing diagnostic work-up or have a recent (within 90 days), treatment-naïve confirmed diagnosis.

Not a fit: People under age 45, those without symptoms or clinical findings suggesting cancer, or patients who have already started cancer treatment are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, these blood tests could provide a less invasive way to help detect cancer earlier and guide which patients need more urgent diagnostic work-up.

How similar studies have performed: Prior work on blood-based and multi-cancer early detection tests has shown promising but variable results, and larger blinded validation studies are still needed.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Coronado, California and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CancerDiagnosticOncologyTestObservational
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.