Condition: Cancer · Sponsor: Harbinger Health
Interested? Contact the study team ↓
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.
This description comes directly from the study's public registry record.
Sara Bardwell · (617) 446-9266 · sbardwell@harbinger-health.com
Nate Ruffle-Deignan · nrdeignan@harbinger-health.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: 1. Subjects aged ≥45 years at the time of informed consent 2. Provided written or electronic informed consent, according to local guidelines, signed and dated by the Subject or by a legal guardian prior to the performance of any study- specific procedures, sampling, or analyses 3. Presentation with symptoms, signs, and/or findings that raise clinical suspicion of one or more of the protocol-specified sites AND 1. undergoing diagnostic work-up to determine if cancer is present, but do not yet have a confirmed cancer diagnosis. Subject must be willing to undergo a standard diagnostic work-up per local SoC to establish clinical truth regarding the presence or absence of cancer OR 2. have a confirmed diagnosis of cancer, determined within 90 days prior to signing the Informed Consent Form, based on standard diagnostic procedures (histopathology, imaging, etc.) following presentation with symptoms, signs, and/or findings that raised a clinical suspicion of one or more cancers originating from the protocol-specified sites. Must be treatment-naïve for the diagnosed cancer at the time of enrollment. Exclusion Criteria: 1. History of any prior invasive or hematological malignancy (Individuals with completely resected ductal carcinoma in-situ or completely resected non-melanoma skin cancer are permitted) 2. Subject is suffering from any febrile illness defined as a temperature \>101.5°F within 48 hours prior to blood draw 3. Subject is pregnant (Self-reported) 4. Subject is a recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Subject with a corneal transplant can be considered for study entry) 5. Inability or unwillingness to comply with study procedures or follow-up requirement 6. Previous or current participation in any study sponsored by, or employment with, Harbinger Health 7. Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes 8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Southern California Research Center | Coronado, California, United States | Recruiting |
| Palomar Health | Poway, California, United States | Recruiting |
| South Coast Gynecologic Oncology | San Diego, California, United States | Recruiting |
| Rocky Mountain Gastroenterology | Centennial, Colorado, United States | Recruiting |
| Zoyla Almeida, MD PA | Coconut Creek, Florida, United States | Recruiting |
| Azzi ENT and Facial Reconstructive Surgery | Jupiter, Florida, United States | Recruiting |
| Prophase, LLC | Margate, Florida, United States | Recruiting |
| Millennium Medical Research | Miami, Florida, United States | Recruiting |
| Regis Clinical Research | Miami, Florida, United States | Recruiting |
| Gastroenterology of Greater Orlando | Orange City, Florida, United States | Recruiting |
| Millennium Physician Group | Port Charlotte, Florida, United States | Withdrawn |
| Stuart Oncology Associates | Stuart, Florida, United States | Recruiting |
+ 27 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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