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

• ClinicalTrials.gov Identifier: NCT05435066
• Recruitment Status: Recruiting
• First Posted: June 28, 2022
• Last Update Posted: April 11, 2024
• Sponsor: Harbinger Health
• Information provided by (Responsible Party): Harbinger Health

Tracking Information

• First Submitted Date: June 14, 2022
• First Posted Date: June 28, 2022
• Last Update Posted Date: April 11, 2024
• Actual Study Start Date: June 21, 2022
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2024)

• 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

Original Primary Outcome Measures (submitted: June 27, 2022)

• 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
• 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
• 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

Current Secondary Outcome Measures (submitted: April 9, 2024)

• Evaluate performance of the Harbinger Health Test by tumor stage [ Time Frame: Up to 12 months ]
  Assess Harbinger Health test performance with repeat of primary subgroup analysis through Tumor Stage within Cancer Type.
• Evaluate performance of the Harbinger Health Test to discriminate hyperplasia Advanced Adenoma. [ Time Frame: Up to 12 months ]
  Assess Harbinger Health test performance by repeat of Primary with Subgroup Analysis of Non-Cancer vs. Hyperplasia (Advanced Adenoma).

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Newly diagnosed cancer subjects and non-cancer subjects
• Condition: Cancer

Intervention

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 non-cancer controls. The non-cancer controls will be followed for up to 1 year

Study Groups/Cohorts

• Arm 1 - cancer group
  Arm 1 - newly diagnosed cancer subjects
  Intervention: Diagnostic Test: Harbinger Health Test
• Arm 2 - non cancer group
  Arm 2 - non-cancer subjects
  Intervention: Diagnostic Test: Harbinger Health Test

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 27, 2022): 10000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 3, 2026
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Eligibility 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) 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Sarah Cannon Development Innovations, LLC; 844-710-6157; SCRI.InnovationsMedical@scri.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05435066
• Other Study ID Numbers: HH-PRT-0001; Tissue 32 ( Other Identifier: SCDI )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Harbinger Health
• Original Responsible Party: Same as current
• Current Study Sponsor: Harbinger Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Dax Kurbegov, MD; Sarah Cannon Development Innovations
• Study Director: May Orfali, MD; Harbinger Health

• PRS Account: Harbinger Health
• Verification Date: April 2024