NCT05435066已完成不适用
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
Harbinger Health114 个研究点 分布在 1 个国家目标入组 8,038 人开始时间: 2022年6月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8,038
- 试验地点
- 114
- 主要终点
- Detection of cancer or non-cancer using Harbinger Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Detection of cancer or non-cancer using Harbinger Test
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Evaluate performance of the Harbinger Health Test by tumor stage(Up to 12 months)
- Evaluate performance of the Harbinger Health Test to discriminate hyperplasia Advanced Adenoma.(Up to 12 months)
研究者
研究点 (114)
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相关资讯
Harbinger Health's Blood-Based Multi-Cancer Test Shows Promise in High-Risk Obesity Population at ASCO 2025- Harbinger Health presented clinical data at ASCO 2025 demonstrating their blood-based multi-cancer early detection test achieved 25.8% sensitivity for early-stage cancers and 80.3% for late-stage cancers at 98.3% specificity in high-risk populations.
- The CORE-HH study enrolled 8,095 subjects from 126 U.S. sites, with the obesity cohort of 762 individuals showing the test's ability to detect cancers that disproportionately affect obese patients and lack established screening programs.
- The company's ctDNA-methylation-based reflex testing system introduces a novel "intrinsic accuracy" metric of 36%, measuring the test's ability to correctly identify both cancer presence and tissue of origin.
- In a modeled 100,000-person cohort, the test identified 51 of 86 pancreaticobiliary cancers, including 8 of 31 early-stage cases, addressing a critical gap for cancers without routine screening programs.last yearHarbinger Health Partners with Memorial Sloan Kettering to Accelerate Early Cancer Detection Test Validation- Harbinger Health collaborates with Memorial Sloan Kettering to expedite clinical validation of its AI-supported blood test for early-stage cancer detection.
- The test, based on methylation pattern analysis, aims to detect the 20 most prevalent cancer types before metastasis, ideally at stage I.
- The partnership seeks to broaden patient recruitment, refine diagnostic tests, and conduct real-world studies for regulatory submissions.
- Harbinger Health's test is based on insights into the biology of cancer origins, potentially transforming cancer diagnosis and management.last year