Prospective Study to Assess a Diagnostic Aid for Cancer

Recruiting now

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT07046260

Run by

Harbinger Health

People needed

1650

Starts

2025-07-11

Expected to finish

2026-11-01

Last updated by the study team

2026-03-11

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Activian Clinical Research — Kingwood, Texas, United States (enrolling)
• Palomar Health — Poway, California, United States (enrolling)
• South Coast Gynecologic Oncology — San Diego, California, United States (enrolling)
• Rocky Mountain Gastroenterology — Centennial, Colorado, United States (enrolling)
• Zoyla Almeida, MD PA — Coconut Creek, Florida, United States (enrolling)
• Azzi ENT and Facial Reconstructive Surgery — Jupiter, Florida, United States (enrolling)
• Prophase, LLC — Margate, Florida, United States (enrolling)
• Millennium Medical Research — Miami, Florida, United States (enrolling)
• Regis Clinical Research — Miami, Florida, United States (enrolling)
• Gastroenterology of Greater Orlando — Orange City, Florida, United States (enrolling)
• Texas Digestive — Harlingen, Texas, United States (enrolling)
• Activian Clinical Research (Scarsdale) — Houston, Texas, United States (enrolling)
• Huntsville Research Institute, LLC — Huntsville, Texas, United States (enrolling)
• Southern California Research Center — Coronado, California, United States (enrolling)
• Stuart Oncology Associates — Stuart, Florida, United States (enrolling)
• Avita Clinical Research — Tampa, Florida, United States (enrolling)
• Cancer Center of Middle Georgia — Dublin, Georgia, United States (enrolling)
• Pulmonary & Sleep Specialists of Northeast Georgia, P.C — Winder, Georgia, United States (enrolling)
• Christie Clinic — Champaign, Illinois, United States (enrolling)
• Hope and Healing Cancer Services — Hinsdale, Illinois, United States (enrolling)
• Iowa Clinic — West Des Moines, Iowa, United States (enrolling)
• Hutchinson Clinic — Hutchinson, Kansas, United States (enrolling)
• Northlake Gastroenterology Associates — Hammond, Louisiana, United States (enrolling)
• Velocity Clinical Research — Annapolis, Maryland, United States (enrolling)
• Oncology Hematology Specialists — Mountain Lakes, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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