What is this study trying to find out about cancer?

This study is evaluating two blood-based tests to help detect cancers in people with symptoms or signs suggestive of cancer. Researchers want to understand how well these tests perform in identifying cancer cases. The study is sponsored by Harbinger Health and focuses on improving cancer diagnosis methods.

Who may be eligible for this cancer clinical trial?

Adults aged 45 years or older who have symptoms or signs that suggest possible cancer or have recently been diagnosed with cancer but have not started treatment may be eligible. The study includes all genders and requires willingness to undergo standard diagnostic tests. Please review eligibility criteria for more details.

Is there any cost to participate in this cancer clinical trial?

Study-related care, including the blood sample collection and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Age: 45Years +

All Genders

ID07046260

Prospective Cohort Study to Assess Two Blood-Based Diagnostic Aid Tests for Cancer Detection in Symptomatic Adults Aged 45 and Older PROCARES

Led by Harbinger Health · Updated on 2026-03-11

1650

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the performance of two blood-based diagnostic tests designed to help detect cancer in individuals aged 45 and older who show symptoms, signs, or findings that suggest cancer. The study aims to assess these tests in people suspected of having cancer or those recently diagnosed but not yet treated. This observational study is sponsored by Harbinger Health and focuses on cancers originating from specific sites outlined in the study protocol. Participants will provide a blood sample of up to 40 mL collected in special tubes for analysis by the investigational diagnostic tests. Those with suspected cancer will undergo a standard diagnostic work-up to confirm if cancer is present, while those already diagnosed must be treatment-nave. The results of the diagnostic tests will not be shared with patients or doctors and will not influence clinical decisions. All testing and analyses are conducted in a blinded manner. During the study, participants will complete a blood draw and follow the usual diagnostic procedures as needed. Researchers will track clinical outcomes, diagnostic test performance, and cancer incidence over 18 months. The main measure is how well the two diagnostic tests identify cancer among participants showing relevant symptoms or signs. Safety and adherence will be monitored, but the study does not involve treatment. Total participation duration may vary depending on diagnostic and follow-up processes.

CONDITIONS

Brief Title

Prospective Study to Assess a Diagnostic Aid for Cancer

Who Can Participate

Age: 45Years +

All Genders

Eligibility Criteria

You may qualify if you...

Subjects aged 45 years or older at the time of consent
Provided signed written or electronic informed consent
Presenting with symptoms, signs, or findings that raise suspicion of one or more specified cancers
Undergoing diagnostic work-up to determine cancer presence but not yet diagnosed, or
Have a confirmed cancer diagnosis within 90 days prior to consent and are treatment-na�ve for this cancer

You will not qualify if you...

History of any prior invasive or blood-related cancer (except fully removed ductal carcinoma in-situ or non-melanoma skin cancer)
Febrile illness with temperature over 101.5°F within 48 hours before blood draw
Currently pregnant (self-reported)
Recipient of organ transplant, blood transfusion within 120 days, or prior non-autologous bone marrow or stem cell transplant (corneal transplant allowed)
Unable or unwilling to comply with study procedures or follow-up
Previous or current participation or employment with Harbinger Health
Participation in another clinical research study that may interfere with this study
Any condition that the investigator believes should prevent participation

Research Team

Sara Bardwell

Nate Ruffle-Deignan

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