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Development and Validation of Harbinger Health Test for Early Cancer Detection | Clinical Trials | Clareo Health

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Development and Validation of Harbinger Health Test for Early Cancer Detection

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

NCT05435066•Harbinger Health

View on ClinicalTrials.gov

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

Age

20 - 79 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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
•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
•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 :
+2 more criteria

Exclusion Criteria

•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).
•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;
+6 more criteria

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

Key Dates

Start Date

June 21, 2022

Primary Completion Date

June 11, 2025

Completion Date

June 11, 2025

Last Updated

July 29, 2025

Enrollment

8,038

ACTUAL participants

Conditions

Cancer

Interventions

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Development and Validation of Harbinger Health Test for Early Cancer Detection

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells