Prospective Study to Assess a Diagnostic Aid for Cancer

NCT07046260 | Recruiting

• 1 other identifier: HH-PRT-0005
• Study Type: observational
• Target: 1,650
• Locations: 1 country
• Sites: 39

Brief 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.

Conditions

Cancer

Keywords

Cancer; Diagnostic; Oncology; Test; Observational

Outcome Measures

Primary Outcomes (1)

• Performance of two diagnostic aid tests 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) and gastrointestinal-focused (GI) test

  * Predictive value of the Harbinger multi-cancer (MC) test by each readout category. * Predictive value of the Harbinger GI test by each readout category.

  18 months

Secondary Outcomes (2)

• Quantify test readout distribution, likelihood ratio, and marginal classification distribution of each Harbinger test

  18 months

• Establish cancer incidence in this intended use population

  18 months

Study Arms (1)

Patients with clinical suspicion of cancer or patients recently diagnosed with Cancer

Individuals 45 years of age or older who have signs, symptoms, and/or findings that their doctor suspects may be related to cancer, or who have recently been diagnosed with cancer and have not received treatment for this cancer.

Other: Blood sample collection

Interventions

Blood sample collection OTHER

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

Also known as: Diagnostic Aid Test

Patients with clinical suspicion of cancer or patients recently diagnosed with Cancer

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll individuals 45 years of age or older who present with symptoms, signs, and/or have findings leading to a clinical suspicion or a diagnosis of one or more cancers originating from the following sites: * Biliary Tract * Colon * Esophagogastric Junction (EGJ) * Esophagus * Gallbladder * Head and Neck * Liver * Lung * Lymphatic System * Ovary * Pancreas * Rectum * Stomach

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

Sponsors & Collaborators

• Harbinger Health: lead

Study Sites (39)

Southern California Research Center

Coronado, California, 92118, United States

RECRUITING

Palomar Health

Poway, California, 92064, United States

RECRUITING

South Coast Gynecologic Oncology

San Diego, California, 92108, United States

RECRUITING

Rocky Mountain Gastroenterology

Centennial, Colorado, 80112, United States

RECRUITING

Zoyla Almeida, MD PA

Coconut Creek, Florida, 33073, United States

RECRUITING

Azzi ENT and Facial Reconstructive Surgery

Jupiter, Florida, 33477, United States

RECRUITING

Prophase, LLC

Margate, Florida, 33063, United States

RECRUITING

Millennium Medical Research

Miami, Florida, 33126, United States

RECRUITING

Regis Clinical Research

Miami, Florida, 33126, United States

RECRUITING

Gastroenterology of Greater Orlando

Orange City, Florida, 32763, United States

RECRUITING

Millennium Physician Group

Port Charlotte, Florida, 33952, United States

WITHDRAWN

Stuart Oncology Associates

Stuart, Florida, 34994, United States

RECRUITING

Avita Clinical Research

Tampa, Florida, 33613, United States

RECRUITING

Cancer Center of Middle Georgia

Dublin, Georgia, 31021, United States

RECRUITING

Pulmonary & Sleep Specialists of Northeast Georgia, P.C

Winder, Georgia, 30680, United States

RECRUITING

Christie Clinic

Champaign, Illinois, 61820, United States

RECRUITING

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

RECRUITING

Iowa Clinic

West Des Moines, Iowa, 50266, United States

RECRUITING

Hutchinson Clinic

Hutchinson, Kansas, 67502, United States

RECRUITING

Northlake Gastroenterology Associates

Hammond, Louisiana, 70403, United States

RECRUITING

Velocity Clinical Research

Annapolis, Maryland, 21401, United States

RECRUITING

Capital Digestive Care

Chevy Chase, Maryland, 20815, United States

WITHDRAWN

Huron Gastroenterology

Ypsilanti, Michigan, 48197, United States

WITHDRAWN

Oncology Hematology Specialists

Mountain Lakes, New Jersey, 07046, United States

RECRUITING

Southwest Gastroenterology

Albuquerque, New Mexico, 87109, United States

WITHDRAWN

Westchester Putnam Gastro

Carmel, New York, 10512, United States

RECRUITING

Associated Gastroenterologists of Central New York

Fayetteville, New York, 13066, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

Wilmington Health, PLLC

Wilmington, North Carolina, 28401, United States

RECRUITING

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

RECRUITING

Susquehanna Research Group

Harrisburg, Pennsylvania, 17110, United States

RECRUITING

Respiratory Specialists

Wyomissing, Pennsylvania, 19610, United States

RECRUITING

Cancer Care Associates of York

York, Pennsylvania, 17403, United States

RECRUITING

GIA Clinical Trials, LLC

Knoxville, Tennessee, 37909, United States

RECRUITING

Premier Family Physicians

Austin, Texas, 78735, United States

RECRUITING

Texas Digestive

Harlingen, Texas, 78550, United States

RECRUITING

Activian Clinical Research (Scarsdale)

Houston, Texas, 77089, United States

RECRUITING

Huntsville Research Institute, LLC

Huntsville, Texas, 77340, United States

RECRUITING

Activian Clinical Research

Kingwood, Texas, 77339, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Neoplasms; Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luke Pike, MD, DPhil

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Bardwell

CONTACT

(617) 446-9266; sbardwell@harbinger-health.com

Nate Ruffle-Deignan

CONTACT

nrdeignan@harbinger-health.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 1, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (39)