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NCT07046260Recruiting

Prospective Study to Assess a Diagnostic Aid for Cancer

Harbinger Health

Start Date

7/11/2025

Completion Date

11/1/2026

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.

Detailed 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.

Eligibility Criteria

Age Range: 45 years to No maximum

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

Interventions

OTHER

Blood sample collection

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Conditions

Cancer

Locations

Southern California Research Center

Coronado, California 92118

United States

Palomar Health

Poway, California 92064

United States

South Coast Gynecologic Oncology

San Diego, California 92108

United States

Rocky Mountain Gastroenterology

Centennial, Colorado 80112

United States

Zoyla Almeida, MD PA

Coconut Creek, Florida 33073

United States

Azzi ENT and Facial Reconstructive Surgery

Jupiter, Florida 33477

United States

Prophase, LLC

Margate, Florida 33063

United States

Millennium Medical Research

Miami, Florida 33126

United States

Regis Clinical Research

Miami, Florida 33126

United States

Gastroenterology of Greater Orlando

Orange City, Florida 32763

United States

Millennium Physician Group

Port Charlotte, Florida 33952

United States

Stuart Oncology Associates

Stuart, Florida 34994

United States

Avita Clinical Research

Tampa, Florida 33613

United States

Cancer Center of Middle Georgia

Dublin, Georgia 31021

United States

Pulmonary & Sleep Specialists of Northeast Georgia, P.C

Winder, Georgia 30680

United States

Christie Clinic

Champaign, Illinois 61820

United States

Hope and Healing Cancer Services

Hinsdale, Illinois 60521

United States

Iowa Clinic

West Des Moines, Iowa 50266

United States

Hutchinson Clinic

Hutchinson, Kansas 67502

United States

Northlake Gastroenterology Associates

Hammond, Louisiana 70403

United States

Velocity Clinical Research

Annapolis, Maryland 21401

United States

Capital Digestive Care

Chevy Chase, Maryland 20815

United States

Huron Gastroenterology

Ypsilanti, Michigan 48197

United States

Oncology Hematology Specialists

Mountain Lakes, New Jersey 07046

United States

Southwest Gastroenterology

Albuquerque, New Mexico 87109

United States

Westchester Putnam Gastro

Carmel, New York 10512

United States

Associated Gastroenterologists of Central New York

Fayetteville, New York 13066

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

Wilmington Health, PLLC

Wilmington, North Carolina 28401

United States

Hightower Clinical

Oklahoma City, Oklahoma 73102

United States

Susquehanna Research Group

Harrisburg, Pennsylvania 17110

United States

Respiratory Specialists

Wyomissing, Pennsylvania 19610

United States

Cancer Care Associates of York

York, Pennsylvania 17403

United States

GIA Clinical Trials, LLC

Knoxville, Tennessee 37909

United States

Premier Family Physicians

Austin, Texas 78735

United States

Texas Digestive

Harlingen, Texas 78550

United States

Activian Clinical Research (Scarsdale)

Houston, Texas 77089

United States

Huntsville Research Institute, LLC

Huntsville, Texas 77340

United States

Activian Clinical Research

Kingwood, Texas 77339

United States