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RECRUITING

NCT07046260

Prospective Study to Assess a Diagnostic Aid for Cancer

Sponsor: Harbinger Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1650

Start Date

2025-07-11

Completion Date

2026-11

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Cancer

Interventions

OTHER

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.

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

Locations (39)

Southern California Research Center

Coronado, California, United States

Palomar Health

Poway, California, United States

South Coast Gynecologic Oncology

San Diego, California, United States

Rocky Mountain Gastroenterology

Centennial, Colorado, United States

Zoyla Almeida, MD PA

Coconut Creek, Florida, United States

Azzi ENT and Facial Reconstructive Surgery

Jupiter, Florida, United States

Prophase, LLC

Margate, Florida, United States

Millennium Medical Research

Miami, Florida, United States

Regis Clinical Research

Miami, Florida, United States

Gastroenterology of Greater Orlando

Orange City, Florida, United States

Millennium Physician Group

Port Charlotte, Florida, United States

Stuart Oncology Associates

Stuart, Florida, United States

Avita Clinical Research

Tampa, Florida, United States

Cancer Center of Middle Georgia

Dublin, Georgia, United States

Pulmonary & Sleep Specialists of Northeast Georgia, P.C

Winder, Georgia, United States

Christie Clinic

Champaign, Illinois, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Iowa Clinic

West Des Moines, Iowa, United States

Hutchinson Clinic

Hutchinson, Kansas, United States

Northlake Gastroenterology Associates

Hammond, Louisiana, United States

Velocity Clinical Research

Annapolis, Maryland, United States

Capital Digestive Care

Chevy Chase, Maryland, United States

Huron Gastroenterology

Ypsilanti, Michigan, United States

Oncology Hematology Specialists

Mountain Lakes, New Jersey, United States

Southwest Gastroenterology

Albuquerque, New Mexico, United States

Westchester Putnam Gastro

Carmel, New York, United States

Associated Gastroenterologists of Central New York

Fayetteville, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Wilmington Health, PLLC

Wilmington, North Carolina, United States

Hightower Clinical

Oklahoma City, Oklahoma, United States

Susquehanna Research Group

Harrisburg, Pennsylvania, United States

Respiratory Specialists

Wyomissing, Pennsylvania, United States

Cancer Care Associates of York

York, Pennsylvania, United States

GIA Clinical Trials, LLC

Knoxville, Tennessee, United States

Premier Family Physicians

Austin, Texas, United States

Texas Digestive

Harlingen, Texas, United States

Activian Clinical Research (Scarsdale)

Houston, Texas, United States

Huntsville Research Institute, LLC

Huntsville, Texas, United States

Activian Clinical Research

Kingwood, Texas, United States