History of Changes for Study: NCT05435066

Development and Validation of Harbinger Health Test for Early Cancer Detection (CORE-HH)

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Study Record Versions

Version	Submitted Date	Changes
1	June 27, 2022	None (earliest Version on record)
2	July 20, 2022	Recruitment Status, Study Status and Contacts/Locations
3	May 17, 2023	Contacts/Locations and Study Status
4	May 30, 2023	Contacts/Locations and Study Status
5	July 7, 2023	Contacts/Locations and Study Status
6	August 16, 2023	Study Status, Contacts/Locations and Eligibility
7	September 5, 2023	Study Status and Contacts/Locations
8	December 1, 2023	Contacts/Locations and Study Status
9	April 9, 2024	Study Status, Contacts/Locations, Outcome Measures, Eligibility, Groups and Interventions and Study Description

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	HH-PRT-0001
Brief Title:	Development and Validation of Harbinger Health Test for Early Cancer Detection (CORE-HH)
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
Secondary IDs:	Tissue 32 [SCDI]

Study Status


Record Verification:	June 2022
Overall Status:	Not yet recruiting
Study Start:	June 20, 2022
Primary Completion:	July 25, 2023 [Anticipated]
Study Completion:	July 3, 2025 [Anticipated]

First Submitted:	June 14, 2022
First Submitted that Met QC Criteria:	June 27, 2022
First Posted:	June 28, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	June 27, 2022
Last Update Posted:	June 28, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Harbinger Health
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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 40 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.

Detailed Description:

Conditions


Conditions:	Cancer
Keywords:	cancer early detection blood-based cancer screening cfDNA cancer diagnosis

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	10000 [Anticipated]
Number of Groups/Cohorts	2

Groups and Interventions

Groups/Cohorts	Interventions
Arm 1 - cancer group Arm 1 - newly diagnosed cancer subjects	Diagnostic Test: Harbinger Health 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 asymptomatic controls. The asymptomatic controls will be followed for up to 2 years
Arm 2 - non cancer group Arm 2 - non-cancer subjects	Diagnostic Test: Harbinger Health 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 asymptomatic controls. The asymptomatic controls will be followed for up to 2 years

Outcome Measures


Primary Outcome Measures:
1.	Detection of cancer or non-cancer using Harbinger Test [ Time Frame: upto 2 years ] 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
2.	Performance for specific cancer types using Harbinger Test [ Time Frame: upto 2 years ] Sub-analysis by clinical diagnosis of cancer type (e.g. Breast cancer) to determine how well the Harbinger Health test detects specific tumor types
3.	Identify the correct tumor type by Harbinger Test [ Time Frame: upto 2 years ] 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

Eligibility


Study Population:	Newly diagnosed cancer subjects and non-cancer subjects
Sampling Method:	Non-Probability Sample
Minimum Age:	20 Years
Maximum Age:	79 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	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) 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). 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 has a known prior diagnosis of any other type of cancer (except completely resected ductal carcinoma in-situ or non-melanoma skin cancer) separate from the confirmed cancer diagnosis associated with study enrollment. 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. 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.

Contacts/Locations


Central Contact Person:	Sarah Cannon Development Innovations, LLC Telephone: 844-710-6157 Email: CANN.InnovationsMedical@sarahcannon.com
Study Officials:	Dax Kurbegov, MD Study Chair Sarah Cannon Development Innovations
	Jeffrey Gregg, MD Study Director Harbinger Health
Locations:	United States, Tennessee
	HCA research Institute Nashville, Tennessee, United States, 37203 Contact:Principal Investigator: Dax Kurbegov, MD

IPDSharing


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References


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