An observational study in Cancer, sponsored by Harbinger Health. Recruiting at 42 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Harbinger Health · Observational
The primary objective of this study is to establish the performance of two blood-based diagnostic aid test for cancer detection in individuals presenting with symptoms, signs, or findings suggestive of cancer.
Subjects 45 years of age and older presenting with symptoms, signs, and/or findings suggestive of one or more cancers originating from protocol-specified sites will be enrolled. Subjects will complete a blood draw for analysis by the investigational diagnostic aid test. For subjects with suspected cancer at enrollment, clinical outcomes will be determined following completion of a standard-of-care diagnostic work-up as clinically indicated. Subjects with a confirmed cancer diagnosis at enrollment must be treatment-naïve and will have diagnosis details collected at the time of enrollment. The results of the investigational diagnostic aid test will not be provided to investigators, treating clinicians, or subjects. Personnel performing clinical evaluations, determining final diagnoses, or reviewing diagnostic imaging and pathology reports will remain blinded to the results of the investigational test. All testing and associated analyses will be conducted in a blinded fashion, and test results will not inform clinical decision-making.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 2,450 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Harbinger Health is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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This study will enroll individuals 45 years of age or older who present with symptoms, signs, and/or have findings leading to a clinical suspicion or a diagnosis of one or more cancers originating from the following sites:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presentation with symptoms, signs, and/or findings that raise clinical suspicion of one or more of the protocol-specified sites AND
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals 45 years of age or older who have signs, symptoms, and/or findings that their doctor suspects may be related to cancer, or who have recently been diagnosed with cancer and have not received treatment for this cancer.
Other: Blood sample collection
The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each participant.
Also known as: Diagnostic Aid Test
Performance of diagnostic aid test 1 among individuals presenting with symptoms, signs and/or clinical findings suggestive of one or more cancers originating from the protocol-specified sites: a multi-cancer (MC) test
Predictive value of the Harbinger multi-cancer (MC) test by each readout category.
Time frame: 18 months
Performance of diagnostic aid test 2 among individuals presenting with symptoms, signs and/or clinical findings suggestive of one or more cancers originating from the protocol-specified sites: gastrointestinal-focused (GI) test
Predictive value of the Harbinger GI test by each readout category.
Time frame: 18 months
Quantify test readout distribution of each Harbinger test
-Establish for each Harbinger test the classification distributions for non-cancer individuals, and for cancer cases overall and by early-stage (I and II) and late-stage (III and IV) and further by cancer type.
Time frame: 18 months
Quantify the likelihood ratio of each Harbinger test
-Establish for each Harbinger test the likelihood ratio for each readout category, overall, by cancer stage and further by cancer type.
Time frame: 18 months
Quantify the marginal classification distribution of each Harbinger test
To establish for each Harbinger test the classification category frequency distribution
Time frame: 18 months
Establish cancer incidence in intended use population
To establish the cancer incidence, overall and by early-stage (I and II) and late-stage (III and IV) and further by cancer type
Time frame: 18 months
Establish a biorepository of blood samples and corresponding clinical data from cancer and non-cancer individuals to support future biomarker discovery and developmental research activities
Prospectively collect blood samples and standardized clinical data (demographics, clinical presentation, diagnostic confirmation, and comorbidities) from confirmed cancer cases and non-cancer controls; ensuring that sample processing and future analyses are conducted in a blinded manner
Time frame: 18 months
Establish a biorepository of blood samples and corresponding clinical data from cancer and non-cancer individuals to support future biomarker discovery and developmental research activities
Process and store samples under controlled conditions using standardized protocols
Time frame: 18 months
Establish a biorepository of blood samples and corresponding clinical data from cancer and non-cancer individuals to support future biomarker discovery and developmental research activities
Ensure all procedures adhere to ethical and regulatory standards. To establish an exploratory biorepository comprising blood samples and corresponding clinical data from cancer and non-cancer participants
Time frame: 18 months
Establish a biorepository of blood samples and corresponding clinical data from cancer and non-cancer individuals to support future biomarker discovery and developmental research activities
To support developmental training activities aimed at refining assay algorithms and optimizing test performance
Time frame: 18 months
Establish a biorepository of blood samples and corresponding clinical data from cancer and non-cancer individuals to support future biomarker discovery and developmental research activities
To perform high-throughput molecular analyses (e.g., genomics, proteomics) on selected specimens for the identification of novel biomarkers
Time frame: 18 months
To conduct stratified analyses of the Primary Objectives
To evaluate the performance of each Harbinger test in-line with the Primary Objectives separately in subgroups defined by age \< 65 versus ≥65 years and in reported male biological sex versus female biological sex.
Time frame: 18 months
To establish the Cancer Signal of Origin Predictive Value for the Harbinger MC test
For the Harbinger MC test, to evaluate the Predictive Value of the Cancer Signal of Origin (CSO) readout
Time frame: 18 months
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Plan to share: Undecided
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