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RecruitingObservational

Prospective Cohort Study With Case Enrichment to Assess a Diagnostic Aid for Cancer in Symptomatic Subjects (PROCARES)

NCT ID: NCT07046260Sponsor: Harbinger HealthLast updated: 2026-03-11

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.

Arms & interventions

  • OtherBlood sample collection

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

Outcome measures

Primary

  • 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.

    Time frame: 18 months

Secondary

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

    Time frame: 18 months

  • Establish cancer incidence in this intended use population

    Time frame: 18 months

Eligibility criteria

Sex: AllAge: 45 Years and olderHealthy 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

Study locations (39)

Southern California Research Center

Coronado, California, 92118

Recruiting

Palomar Health

Poway, California, 92064

Recruiting
Gladiz Ponce · Contact

South Coast Gynecologic Oncology

San Diego, California, 92108

Recruiting
Devon Fahlsing · Contact

Rocky Mountain Gastroenterology

Centennial, Colorado, 80112

Recruiting

Zoyla Almeida, MD PA

Coconut Creek, Florida, 33073

Recruiting
Danielle Fritz · Contact

Azzi ENT and Facial Reconstructive Surgery

Jupiter, Florida, 33477

Recruiting
Natasha Rodriguez · Contact

Prophase, LLC

Margate, Florida, 33063

Recruiting

Millennium Medical Research

Miami, Florida, 33126

Recruiting

Regis Clinical Research

Miami, Florida, 33126

Recruiting

Gastroenterology of Greater Orlando

Orange City, Florida, 32763

Recruiting
Douglas Winter · Contact

Millennium Physician Group

Port Charlotte, Florida, 33952

Withdrawn

Stuart Oncology Associates

Stuart, Florida, 34994

Recruiting
Katrina Petters · Contact

Avita Clinical Research

Tampa, Florida, 33613

Recruiting

Cancer Center of Middle Georgia

Dublin, Georgia, 31021

Recruiting

Pulmonary & Sleep Specialists of Northeast Georgia, P.C

Winder, Georgia, 30680

Recruiting

Christie Clinic

Champaign, Illinois, 61820

Recruiting

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521

Recruiting
Ava Baftirovska · Contact

Iowa Clinic

West Des Moines, Iowa, 50266

Recruiting

Hutchinson Clinic

Hutchinson, Kansas, 67502

Recruiting

Northlake Gastroenterology Associates

Hammond, Louisiana, 70403

Recruiting

Velocity Clinical Research

Annapolis, Maryland, 21401

Recruiting

Capital Digestive Care

Chevy Chase, Maryland, 20815

Withdrawn

Huron Gastroenterology

Ypsilanti, Michigan, 48197

Withdrawn

Oncology Hematology Specialists

Mountain Lakes, New Jersey, 07046

Recruiting
Erika Ramirez · Contact

Southwest Gastroenterology

Albuquerque, New Mexico, 87109

Withdrawn

Westchester Putnam Gastro

Carmel, New York, 10512

Recruiting
Sarah Delacruz · Contact

Associated Gastroenterologists of Central New York

Fayetteville, New York, 13066

Recruiting
Tabatha Jackson · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

Recruiting
Emily Carbone · Contact

Wilmington Health, PLLC

Wilmington, North Carolina, 28401

Recruiting

Hightower Clinical

Oklahoma City, Oklahoma, 73102

Recruiting
Jamie Massengill · Contact

Susquehanna Research Group

Harrisburg, Pennsylvania, 17110

Recruiting
Jessica Balay · Contact

Respiratory Specialists

Wyomissing, Pennsylvania, 19610

Recruiting
Lisa Hill · Contact

Cancer Care Associates of York

York, Pennsylvania, 17403

Recruiting
Jennifer Stough · Contact

GIA Clinical Trials, LLC

Knoxville, Tennessee, 37909

Recruiting
Kaitlynn Smith · Contact

Premier Family Physicians

Austin, Texas, 78735

Recruiting
Christy Springs · Contact

Texas Digestive

Harlingen, Texas, 78550

Recruiting
Carlette Villarreal · Contact

Activian Clinical Research (Scarsdale)

Houston, Texas, 77089

Recruiting
Marcus Sevier · Contact

Huntsville Research Institute, LLC

Huntsville, Texas, 77340

Recruiting
Nicole Sehgal · Contact

Activian Clinical Research

Kingwood, Texas, 77339

Recruiting
Katie Thomas · Contact