--- title: Development and Validation of Harbinger Health Test for Early Cancer Detection nct_id: NCT05435066 overall_status: COMPLETED sponsor: Harbinger Health study_type: OBSERVATIONAL primary_condition: Cancer countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05435066.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05435066" ct_last_update_post_date: 2025-07-29 last_seen_at: "2026-05-12T07:08:20.885Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Development and Validation of Harbinger Health Test for Early Cancer Detection **Official Title:** Cancer ORigin Epigenetics-Harbinger Health - Collection of Blood and Tissue Samples From Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test **NCT ID:** [NCT05435066](https://clinicaltrials.gov/study/NCT05435066) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 8038 - **Lead Sponsor:** Harbinger Health - **Conditions:** Cancer - **Start Date:** 2022-06-21 - **Completion Date:** 2025-06-11 - **CT.gov Last Update:** 2025-07-29 ## Brief Summary This is a prospective, multi-center, observational study with a collection of biospecimens and clinical data from approximately 10,000 participants from up to 125 clinical network sites and locations in the United States. The objective of this study is to collect blood samples, tissue samples, and associated clinical data from participants with a variety of solid tumor and hematologic cancers and non-cancer participants for testing and the development of a screening test for early cancer detection. ## Eligibility - **Minimum age:** 20 Years - **Maximum age:** 79 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: * Inclusion Criteria - Both arms Subjects must meet the following criteria in order to be included in the research study: * Written or electronic informed consent * Subject is 20 - 79 years of age at the time of signature of the informed consent form (ICF) * Male or female subjects Inclusion Criteria Arm 1 - Cancer Subjects Arm 1 subjects enrolled in the study must meet the following inclusion criteria. * A confirmed diagnosis or high suspicion of cancer (stage I to IV solid cancer or hematologic cancer) by imaging within 180 days prior to enrollment; not to include myelodysplastic and myeloproliferative syndromes * Subject's cancer diagnosis is based upon assessment of a pathological specimen or high suspicion of cancer by imaging * Subject's cancer is treatment-naïve Inclusion Criteria Arm 2 - Non-Cancer Subjects (All Cohorts) Arm 2 subjects enrolled in the study must meet the following inclusion criteria: * Subject's health permits participation and the subject is not suspected of having cancer based on provider assessment. * The subject was not diagnosed with cancer or received cancer treatment within the last 5 years (persons with completely resected ductal carcinoma in-situ or non-melanoma skin cancer are permitted). Part 1B Only : \- Subject has no known current cancer and has 1 of the follow conditions: o An Advanced Adenoma (AA) of the gastrointestinal tract as defined as an adenoma that is ≤10mm in size Subjects with any one of the criteria would be eligible High grade displasia or ≥10 adenoma: any size Tubulovillous adenoma, any size Tubular adenoma ≥10mm Traditional serrated adenoma ≥10mm Exclusion Criteria: Subject self-reporting OR available medical records at the time of screening are acceptable for assessment of all exclusion criteria. Exclusion Criteria - Both arms Subjects who meet any of the following criteria will be excluded from study entry: * Subject is suffering from any febrile illness defined as a temperature \>101.5°F within the last 48 hrs. * Subject is pregnant (by self-report of pregnancy status). Exclusion Criteria Arm 1 - Cancer Subjects Subjects who meet any of the following criteria will be excluded from study entry: * Subject with a prior history of cancer within 5 years will not be allowed to participate in the study * More than 1 active cancer diagnosis (ie. a subject presenting with recurrent breast cancer and newly diagnosed lung cancer would be excluded; subject with prior (\>5 years ago) treated breast cancer without recurrence and presenting with newly diagnosed lung cancer would be eligible). * Subject is currently receiving, or has in the past received, any of the following definitive therapies to treat their current cancer: * Surgical treatment, surgical removal, or surgical management of the cancer beyond that required to establish the cancer diagnosis. Surgical or biopsy procedures that remove more tissue than required to establish the cancer diagnosis, or that were performed to manage symptoms or initiate cancer treatment prior to blood sample collection will be considered 'definitive' and are not permissible regardless of the residual tumor mass remaining in the subject. * Chemotherapy (local, regional, or systemic) including chemoembolization targeted therapy; * Immunotherapy including cancer vaccines; * Hormone therapy; or * Radiation therapy (a single dose of palliative radiation prior to study start is allowed). * The subject is a recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. * Subject who has undergone a bowel preparation for a gastrointestinal malignancy within 3 days of an anticipated blood draw. Exclusion Criteria Arm 2 - Non-cancer Subjects Subjects who meet any of the following criteria will be excluded from study entry: \- The subject is the recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. ``` ## Arms - **Arm 1 - cancer group** — Arm 1 - newly diagnosed cancer subjects - **Arm 2 - non cancer group** — Arm 2 - non-cancer subjects ## Interventions - **Harbinger Health Test** (DIAGNOSTIC_TEST) — This trial will be used to test the ability of the Harbinger Health test to detect cancer using blood-based biomarkers in a large cohort of patients with cancer and matched non-cancer controls. The non-cancer controls will be followed for up to 1 year ## Primary Outcomes - **Detection of cancer or non-cancer using Harbinger Test** _(time frame: Up to 12 months)_ — Analyze Subject's cfDNA from blood samples for "cancer" or "non-cancer" signals using the Harbinger Health test, and compare results of the test to clinical diagnosis - **Performance for specific cancer types using Harbinger Test** _(time frame: Up to 12 months)_ — Sub-analysis by clinical diagnosis of cancer type (e.g. Breast cancer) to determine how well the Harbinger Health test detects specific tumor types - **Identify the correct tumor type by Harbinger Test** _(time frame: Up to 12 months)_ — Analyze Subject's cfDNA from blood samples to accurately identify specific tumor types (e.g. Breast cancer) using the Harbinger Health test, by comparing results of the test to clinical diagnosis ## Secondary Outcomes - **Evaluate performance of the Harbinger Health Test by tumor stage** _(time frame: Up to 12 months)_ - **Evaluate performance of the Harbinger Health Test to discriminate hyperplasia Advanced Adenoma.** _(time frame: Up to 12 months)_ ## Locations (128) - Southern Cancer Center, Daphne, Alabama, United States - Alaska Oncology and Hematology, LLC, Anchorage, Alaska, United States - Alaska Womens Cancer Care, Anchorage, Alaska, United States - Arizona Oncology Associates HAL, Prescott Valley, Arizona, United States - Pacific Cancer Medical Center, Anaheim, California, United States - Central California ENT Medical Group, Fresno, California, United States - South Coast Gynecologic Oncology, Inc, San Diego, California, United States - South Coast Gynecologic Oncology, INC, San Diego, California, United States - Sansum Clinic, Santa Barbara, California, United States - Gynecologic Oncology Associates, Torrance, California, United States - Colorado Primary Health Care, Littleton, Colorado, United States - Medical Oncology Hematology Consultants, PA, Newark, Delaware, United States - Central Florida Pulmonary Group - Altamonte Springs, Altamonte Springs, Florida, United States - ENT and Allergy Associates of Florida, LLC, Boca Raton, Florida, United States - Plastic Surgery Specialists of Boca Raton, Boca Raton, Florida, United States - ENT and Allergy Associates of Florida, LLC, Boca Raton, Florida, United States - South Florida Center for Gynecologic Oncology, Boca Raton, Florida, United States - Urology Center of South Florida, Boynton Beach, Florida, United States - Advanced Cancer Surgery and Digestive Health, Boynton Beach, Florida, United States - ENT and Allergy Associates of Florida, LLC, Brandon, Florida, United States - Zoyla Almedia, MD PA, Coconut Creek, Florida, United States - ENT and Allergy Associates of Florida, LLC, Ft. Pierce, Florida, United States - Stuart Oncology Associates, Ft. Pierce, Florida, United States - I.H.S. Health, Kissimmee, Florida, United States - ENT and Allergy Associates of Florida, LLC - Okeechobee, Okeechobee, Florida, United States - Central Florida Pulmonary Group, Orlando, Florida, United States - Central Florida Pulmonary Group - Dylan Loren Cir, Orlando, Florida, United States - Cancer Care Centers of Brevard, Palm Bay, Florida, United States - ENT and Allergy Associates of Florida, LLC, Palm Beach Gardens, Florida, United States - Woodlands Medical Specialists, Pensacola, Florida, United States - ENT and Allergy Associates of Florida, LLC, Plantation, Florida, United States - ENT and Allergy Associates of Florida, LLC, Port Saint Lucie, Florida, United States - Stuart Oncology Associates, Port Saint Lucie, Florida, United States - Stuart Oncology Associates, Port Saint Lucie, Florida, United States - Stuart Oncology Associates, Stuart, Florida, United States - ENT and Allergy Associates of Florida, LLC, Wesley Chapel, Florida, United States - ENT and Allergy Associates of Florida, LLC, West Palm Beach, Florida, United States - Advanced Urology - John's Creek, Johns Creek, Georgia, United States - Advanced Urology - Lawrenceville, Lawrenceville, Georgia, United States - Advanced Urology - Marietta, Marietta, Georgia, United States - Advanced Urology - Rosewell, Roswell, Georgia, United States - Advanced Urology - Snellville, Snellville, Georgia, United States - Illinois Cancer Specialists, Arlington Heights, Illinois, United States - Hope and Healing Cancer Services, Hinsdale, Illinois, United States - Hem/Onc of the North Shore, Skokie, Illinois, United States - Evansville Surgical Associates-Mary Street, Evansville, Indiana, United States - Evansville Surgical Associates-Mary's Drive, Evansville, Indiana, United States - Evansville Surgical Associates-Gateway Boulevard, Newburgh, Indiana, United States - Mission Cancer and Blood, Des Moines, Iowa, United States - Wichita Urology Group - W. 21st Street, Wichita, Kansas, United States - Wichita Urology Group- P.A. - 2077 N. Webb Road, Wichita, Kansas, United States - Breast Care Specialists, Wichita, Kansas, United States - Kansas Surgery & Recovery Center, Wichita, Kansas, United States - Wichita Urology Group- 2626 Webb Road, Wichita, Kansas, United States - Northlake Gastroenterology Associates, Hammond, Louisiana, United States - Northlake Gastroenterology Associates, Hammond, Louisiana, United States - Maryland Oncology Hematology, Columbia, Maryland, United States - Comprehensive Urology - Farmington Hills, Farmington Hills, Michigan, United States - Comprehensive Urology - Novi, Novi, Michigan, United States - Comprehensive Urology - Roseville, Roseville, Michigan, United States - Michigan Cancer Specialists, Roseville, Michigan, United States - Comprehensive Urology - Royal Oak, Royal Oak, Michigan, United States - Comprehensive Urology - Sterling Heights, Sterling Heights, Michigan, United States - Minnesota Oncology Hematology, Minneapolis, Minnesota, United States - Somnos Clinical Research, Lincoln, Nebraska, United States - Hope Cancer Care of Nevada, Las Vegas, Nevada, United States - Cancer Care Specialists - Reno, Reno, Nevada, United States - New Jersey Cancer Care, Belleville, New Jersey, United States - New Jersey Hematology Oncology Associates, Brick, New Jersey, United States - Surgical Specialists of New York - Jersey City, Jersey City, New Jersey, United States - Oncology Hematology Specialists, Mountain Lakes, New Jersey, United States - Center of Dermatology and Skin Surgery, LLC, Paramus, New Jersey, United States - Women's Cancer Care Associates LLC, Albany, New York, United States - Surgical Specialists of NY - Astoria, Astoria, New York, United States - New York Gastroenterology Associates - Pierrepont, Brooklyn, New York, United States - Gardith Joseph Medical P.C. Quality Cancer Care, Brooklyn, New York, United States - Vantage Medical Associates, Brooklyn, New York, United States - Associated Gastroenterologists of Central New York - Camillus, Camillus, New York, United States - Associated Gastroenterologists of Central New York - Syracuse, East Syracuse, New York, United States - Vantage Medical Associates, Far Rockaway, New York, United States - Associated Gastroenterologists of Central New York - Fayetteville, Fayetteville, New York, United States - Hudson Valley Cancer Center - Fishkill, Fishkill, New York, United States - Advanced Urology Centers of NY, Lake Success, New York, United States - Gastroenterology Oncology Associates, Liverpool, New York, United States - New York Gastroenterology Associates - Columbus Ave, New York, New York, United States - New York Gastroenterology Associates - 86th Street, New York, New York, United States - New York Gastroenterology Associates - E 79th St, New York, New York, United States - New York Gastroenterology Associates - 5th Ave, New York, New York, United States - Surgical Specialists of NY - New York City, New York, New York, United States - Advanced Radiation Oncology Services, Nyack, New York, United States - Hematology Oncology Associates of Rockland, Nyack, New York, United States - Hudson Valley Cancer Center - Poughkeepsie, Poughkeepsie, New York, United States - Premier Medical Group of the Hudson Valley, Poughkeepsie, New York, United States - Hirschfeld Oncology, The Bronx, New York, United States - Westmed Medical Group, Woodmere, New York, United States - Hudson Valley Cancer Center - Yorktown Heights, Yorktown Heights, New York, United States - Dayton Physicians Network, Dayton, Ohio, United States - Oncology Associates of Oregon, Eugene, Oregon, United States - Northwest Cancer Specialists-, Portland, Oregon, United States - Eastern Pennsylvania Gastroenterology & Liver Specialists, LLC, Allentown, Pennsylvania, United States - Blair Gastroenterology Associates, Altoona, Pennsylvania, United States - Consultants in Medical Oncology & Hematology, Broomall, Pennsylvania, United States - Pulmonology Associates INC., Wynnewood, Pennsylvania, United States - Pulmonology Associates INC, Wynnewood, Pennsylvania, United States - Cancer Care Associates of York, York, Pennsylvania, United States - GIA Clinical Trials, LLC, Knoxville, Tennessee, United States - Advantage Clinical Research, Nashville, Tennessee, United States - HCA research Institute, Nashville, Tennessee, United States - Meharry Medical College, Nashville, Tennessee, United States - Urology Associates, Nashville, Tennessee, United States - Texas Oncology - West Texas, Amarillo, Texas, United States - Texas Oncology - Gulf Coast, Beaumont, Texas, United States - Texas Oncology - Dallas, Dallas, Texas, United States - Texas Oncology - Presbyterian Cancer Center Dallas, Dallas, Texas, United States - Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States - Texas Oncology-Fort Worth, Fort Worth, Texas, United States - Houston Digestive Diseases Consultants, Houston, Texas, United States - Texas Oncology - McAllen, McAllen, Texas, United States - Texas Oncology - Northeast Texas Cancer and Research, McKinney, Texas, United States - Texas Oncology - Plano East, Plano, Texas, United States - Texas Oncology - Plano West, Plano, Texas, United States - Texas Oncology - San Antonio, San Antonio, Texas, United States - Center for Digestive Disease, Shenandoah, Texas, United States - Texas Oncology - Northeast Texas Cancer and Research, Tyler, Texas, United States - Virginia Cancer Specialists, Fairfax, Virginia, United States - Virginia Oncology Associates, Norfolk, Virginia, United States - Shenandoah Oncology, Winchester, Virginia, United States - Northwest Medical Specialties, PLLC, Tacoma, Washington, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - 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`locations.central florida pulmonary group - dylan loren cir|orlando|florida|united states` — added _(2026-05-12)_ - `locations.cancer care centers of brevard|palm bay|florida|united states` — added _(2026-05-12)_ - `locations.ent and allergy associates of florida, llc|palm beach gardens|florida|united states` — added _(2026-05-12)_ - `locations.woodlands medical specialists|pensacola|florida|united states` — added _(2026-05-12)_ - `locations.ent and allergy associates of florida, llc|plantation|florida|united states` — added _(2026-05-12)_ - `locations.ent and allergy associates of florida, llc|port saint lucie|florida|united states` — added _(2026-05-12)_ - `locations.stuart oncology associates|port saint lucie|florida|united states` — added _(2026-05-12)_ - `locations.stuart oncology associates|stuart|florida|united states` — added _(2026-05-12)_ - `locations.ent and allergy associates of florida, llc|wesley chapel|florida|united states` — added _(2026-05-12)_ - `locations.ent and allergy associates of florida, llc|west palm beach|florida|united states` — added _(2026-05-12)_ - `locations.advanced urology - john's creek|johns creek|georgia|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05435066.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05435066* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*