Prospective Study to Assess a Diagnostic Aid for Cancer
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.
| Condition(s) | Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | 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 Inform |
| Ages | 45 Years |
| Sex | All |
| Lead sponsor | Harbinger Health |
| Locations | Coronado, California, United States; Poway, California, United States; San Diego, California, United States; Centennial, Colorado, United States; Coconut Creek, Florida, United States; Jupiter, Florida, United States (+33 more sites) |
| Start date | 2025-07-11 |
| NCT ID | NCT07046260 |
| Official listing | https://clinicaltrials.gov/study/NCT07046260 |