Prospective Study to Assess a Diagnostic Aid for Cancer

Last updated: March 9, 2026
Sponsor: Harbinger Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Cancer

Treatment

Blood sample collection

Clinical Study ID

NCT07046260
HH-PRT-0005
  • Ages > 45
  • All Genders

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 Criteria

Inclusion

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 ofany study- specific procedures, sampling, or analyses

  3. Presentation with symptoms, signs, and/or findings that raise clinical suspicion ofone or more of the protocol-specified sites AND

  4. undergoing diagnostic work-up to determine if cancer is present, but do not yethave a confirmed cancer diagnosis. Subject must be willing to undergo astandard diagnostic work-up per local SoC to establish clinical truth regardingthe presence or absence of cancer OR

  5. have a confirmed diagnosis of cancer, determined within 90 days prior tosigning 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 cancersoriginating from the protocol-specified sites. Must be treatment-naïve for thediagnosed cancer at the time of enrollment.

Exclusion

Exclusion Criteria:

  1. History of any prior invasive or hematological malignancy (Individuals withcompletely resected ductal carcinoma in-situ or completely resected non-melanomaskin cancer are permitted)

  2. Subject is suffering from any febrile illness defined as a temperature >101.5°Fwithin 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, orprior non-autologous (allogeneic) bone marrow or stem cell transplant (Subject witha 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 organizationwhich may interfere with study procedures or outcomes

  8. Subject has any condition that in the opinion of the Investigator should precludeparticipation in the study

Study Design

Total Participants: 1650
Treatment Group(s): 1
Primary Treatment: Blood sample collection
Phase:
Study Start date:
July 11, 2025
Estimated Completion Date:
November 30, 2026

Study Description

Subjects 45 years of age and older presenting with symptoms, signs, and/or findings suggestive of one or more cancers originating from protocol-specified sites will be enrolled. Subjects will complete a blood draw for analysis by the investigational diagnostic aid test. For subjects with suspected cancer at enrollment, clinical outcomes will be determined following completion of a standard-of-care diagnostic work-up as clinically indicated. Subjects with a confirmed cancer diagnosis at enrollment must be treatment-naïve and will have diagnosis details collected at the time of enrollment. The results of the investigational diagnostic aid test will not be provided to investigators, treating clinicians, or subjects. Personnel performing clinical evaluations, determining final diagnoses, or reviewing diagnostic imaging and pathology reports will remain blinded to the results of the investigational test. All testing and associated analyses will be conducted in a blinded fashion, and test results will not inform clinical decision-making.

Connect with a study center

  • Southern California Research Center

    Coronado, California 92118
    United States

    Active - Recruiting

  • Palomar Health

    Poway, California 92064
    United States

    Active - Recruiting

  • South Coast Gynecologic Oncology

    San Diego, California 92108
    United States

    Active - Recruiting

  • Palomar Health

    Poway 5384690, California 5332921 92064
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology

    Centennial, Colorado 80112
    United States

    Active - Recruiting

  • Rocky Mountain Gastroenterology

    Centennial 5416541, Colorado 5417618 80112
    United States

    Site Not Available

  • Zoyla Almeida, MD PA

    Coconut Creek, Florida 33073
    United States

    Active - Recruiting

  • Azzi ENT and Facial Reconstructive Surgery

    Jupiter, Florida 33477
    United States

    Active - Recruiting

  • Prophase, LLC

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Millennium Medical Research

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Regis Clinical Research

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Gastroenterology of Greater Orlando

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Millennium Physician Group

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Stuart Oncology Associates

    Stuart, Florida 34994
    United States

    Active - Recruiting

  • Avita Clinical Research

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Zoyla Almeida, MD PA

    Coconut Creek 4151455, Florida 4155751 33073
    United States

    Site Not Available

  • Azzi ENT and Facial Reconstructive Surgery

    Jupiter 4160610, Florida 4155751 33477
    United States

    Site Not Available

  • Prophase, LLC

    Margate 4163407, Florida 4155751 33063
    United States

    Site Not Available

  • Millennium Medical Research

    Miami 4164138, Florida 4155751 33126
    United States

    Active - Recruiting

  • Regis Clinical Research

    Miami 4164138, Florida 4155751 33126
    United States

    Site Not Available

  • Gastroenterology of Greater Orlando

    Orange City 4167055, Florida 4155751 32763
    United States

    Site Not Available

  • Millennium Physician Group

    Port Charlotte 4169130, Florida 4155751 33952
    United States

    Site Not Available

  • Stuart Oncology Associates

    Stuart 4174201, Florida 4155751 34994
    United States

    Site Not Available

  • Avita Clinical Research

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • Cancer Center of Middle Georgia

    Dublin, Georgia 31021
    United States

    Active - Recruiting

  • Pulmonary & Sleep Specialists of Northeast Georgia, P.C

    Winder, Georgia 30680
    United States

    Active - Recruiting

  • Pulmonary & Sleep Specialists of Northeast Georgia, P.C

    Winder 4231523, Georgia 4197000 30680
    United States

    Site Not Available

  • Christie Clinic

    Champaign, Illinois 61820
    United States

    Active - Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Christie Clinic

    Champaign 4887158, Illinois 4896861 61820
    United States

    Site Not Available

  • Hope and Healing Cancer Services

    Hinsdale 4896012, Illinois 4896861 60521
    United States

    Site Not Available

  • Iowa Clinic

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Iowa Clinic

    West Des Moines 4881346, Iowa 4862182 50266
    United States

    Site Not Available

  • Hutchinson Clinic

    Hutchinson, Kansas 67502
    United States

    Active - Recruiting

  • Hutchinson Clinic

    Hutchinson 4273299, Kansas 4273857 67502
    United States

    Site Not Available

  • Northlake Gastroenterology Associates

    Hammond, Louisiana 70403
    United States

    Active - Recruiting

  • Northlake Gastroenterology Associates

    Hammond 4326868, Louisiana 4331987 70403
    United States

    Site Not Available

  • Velocity Clinical Research

    Annapolis, Maryland 21401
    United States

    Active - Recruiting

  • Capital Digestive Care

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Velocity Clinical Research

    Annapolis 4347242, Maryland 4361885 21401
    United States

    Site Not Available

  • Capital Digestive Care

    Chevy Chase 4351335, Maryland 4361885 20815
    United States

    Site Not Available

  • Huron Gastroenterology

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Huron Gastroenterology

    Ypsilanti 5015688, Michigan 5001836 48197
    United States

    Site Not Available

  • Oncology Hematology Specialists

    Mountain Lakes, New Jersey 07046
    United States

    Active - Recruiting

  • Oncology Hematology Specialists

    Mountain Lakes 5101585, New Jersey 5101760 07046
    United States

    Site Not Available

  • Southwest Gastroenterology

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Southwest Gastroenterology

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Site Not Available

  • Westchester Putnam Gastro

    Carmel, New York 10512
    United States

    Active - Recruiting

  • Associated Gastroenterologists of Central New York

    Fayetteville, New York 13066
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Active - Recruiting

  • Westchester Putnam Gastro

    Carmel 5111576, New York 5128638 10512
    United States

    Site Not Available

  • Associated Gastroenterologists of Central New York

    Fayetteville 5116968, New York 5128638 13066
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • Wilmington Health, PLLC

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Wilmington Health, PLLC

    Wilmington 4499379, North Carolina 4482348 28401
    United States

    Site Not Available

  • Hightower Clinical

    Oklahoma City, Oklahoma 73102
    United States

    Active - Recruiting

  • Hightower Clinical

    Oklahoma City 4544349, Oklahoma 4544379 73102
    United States

    Site Not Available

  • Susquehanna Research Group

    Harrisburg, Pennsylvania 17110
    United States

    Active - Recruiting

  • Respiratory Specialists

    Wyomissing, Pennsylvania 19610
    United States

    Active - Recruiting

  • Cancer Care Associates of York

    York, Pennsylvania 17403
    United States

    Active - Recruiting

  • Susquehanna Research Group

    Harrisburg 5192726, Pennsylvania 6254927 17110
    United States

    Site Not Available

  • Respiratory Specialists

    Wyomissing 5220248, Pennsylvania 6254927 19610
    United States

    Site Not Available

  • GIA Clinical Trials, LLC

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • GIA Clinical Trials, LLC

    Knoxville 4634946, Tennessee 4662168 37909
    United States

    Site Not Available

  • Premier Family Physicians

    Austin, Texas 78735
    United States

    Active - Recruiting

  • Texas Digestive

    Harlingen, Texas 78550
    United States

    Active - Recruiting

  • Activian Clinical Research (Scarsdale)

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Huntsville Research Institute, LLC

    Huntsville, Texas 77340
    United States

    Active - Recruiting

  • Activian Clinical Research

    Kingwood, Texas 77339
    United States

    Active - Recruiting

  • Premier Family Physicians

    Austin 4671654, Texas 4736286 78735
    United States

    Site Not Available

  • Activian Clinical Research (Scarsdale)

    Houston 4699066, Texas 4736286 77089
    United States

    Site Not Available

  • Huntsville Research Institute, LLC

    Huntsville 4699540, Texas 4736286 77340
    United States

    Site Not Available

  • Activian Clinical Research

    Kingwood 7534469, Texas 4736286 77339
    United States

    Site Not Available

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