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Recruiting Observational

Prospective Study to Assess a Diagnostic Aid for Cancer

NCT07046260 · tracked via the Priya Life Science USA tracker
Sponsor
Harbinger Health
Phase
Observational
Started
2025-07-11
Last updated
2026-09-21

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

Blood sample collection

Blood sample collection: The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each participant.

Study 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

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Performance of diagnostic aid test 1 among individuals presenting with symptoms, signs and/or clinical findings suggestive of one or more cancers originating from the protocol-specified sites: a multi-cancer (MC) test — 18 months
    Predictive value of the Harbinger multi-cancer (MC) test by each readout category.
  • Performance of diagnostic aid test 2 among individuals presenting with symptoms, signs and/or clinical findings suggestive of one or more cancers originating from the protocol-specified sites: gastrointestinal-focused (GI) test — 18 months
    Predictive value of the Harbinger GI test by each readout category.

Trial sites (42)

FacilityCityRegionStatus
Southern California Research Center Coronado California Recruiting
Palomar Health Poway California Recruiting
South Coast Gynecologic Oncology San Diego California Recruiting
Rocky Mountain Gastroenterology Centennial Colorado Recruiting
Zoyla Almeida, MD PA Coconut Creek Florida Recruiting
BioResearch Partner Hialeah Florida Recruiting
Azzi ENT and Facial Reconstructive Surgery Jupiter Florida Recruiting
Prophase, LLC Margate Florida Recruiting
Millennium Medical Research Miami Florida Recruiting
Regis Clinical Research Miami Florida Recruiting
Gastroenterology of Greater Orlando Orange City Florida Recruiting
Millennium Physician Group Port Charlotte Florida Withdrawn
Stuart Oncology Associates Stuart Florida Recruiting
Avita Clinical Research Tampa Florida Recruiting
Cancer Center of Middle Georgia Dublin Georgia Recruiting
Pulmonary & Sleep Specialists of Northeast Georgia, P.C Winder Georgia Recruiting
Christie Clinic Champaign Illinois Recruiting
Hope and Healing Cancer Services Hinsdale Illinois Recruiting
Springfield Clinic Springfield Illinois Recruiting
Iowa Clinic West Des Moines Iowa Recruiting
Hutchinson Clinic Hutchinson Kansas Recruiting
Northlake Gastroenterology Associates Hammond Louisiana Recruiting
Velocity Clinical Research Annapolis Maryland Recruiting
Capital Digestive Care Chevy Chase Maryland Withdrawn
Huron Gastroenterology Ypsilanti Michigan Withdrawn
Aton Health Kansas City Missouri Recruiting
Oncology Hematology Specialists Mountain Lakes New Jersey Recruiting
Southwest Gastroenterology Albuquerque New Mexico Withdrawn
Westchester Putnam Gastro Carmel New York Recruiting
Associated Gastroenterologists of Central New York Fayetteville New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Wilmington Health, PLLC Wilmington North Carolina Recruiting
Hightower Clinical Oklahoma City Oklahoma Recruiting
Susquehanna Research Group Harrisburg Pennsylvania Recruiting
Respiratory Specialists Wyomissing Pennsylvania Recruiting
Cancer Care Associates of York York Pennsylvania Recruiting
GIA Clinical Trials, LLC Knoxville Tennessee Recruiting
Premier Family Physicians Austin Texas Recruiting
Texas Digestive Harlingen Texas Recruiting
Activian Clinical Research (Scarsdale) Houston Texas Withdrawn

+ 2 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07046260 on ClinicalTrials.gov ↗ ← All trials in the USA