Development and Validation of Harbinger Health Test for Early Cancer Detection (NCT05435066) | Clinical Trial Compass
CompletedNot Applicable
Development and Validation of Harbinger Health Test for Early Cancer Detection
United States8,038 participantsStarted 2022-06-21
Plain-language 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.
Who can participate
Age range
20 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Detection of cancer or non-cancer using Harbinger Test
Timeframe: Up to 12 months
2
Performance for specific cancer types using Harbinger Test