Colorectal Cancer (Diagnosis)
Conditions
Keywords
Colorectal cancer, Cancer, Diagnostic test, Blood test, Oncology
Brief summary
The primary objective of this study is to evaluate a blood-based screening test for Colorectal Cancer (CRC).
Detailed description
Participants 45 years and older who are at average risk for colorectal cancer (CRC) with a positive multitarget stool DNA (mt-sDNA) screening test result and scheduled to undergo diagnostic colonoscopy as part of standard clinical care within 60 days of providing informed consent (Cohort 1), and participants with confirmed CRC diagnosed within 90 days prior to providing informed consent, based on standard diagnostic procedures (Cohort 2), will be enrolled. Participants enrolled with confirmed CRC must be treatment-naïve at the time of enrollment. A one-time blood sample will be collected from all enrolled participants within 14 days of signing the informed consent form. Participation will be completed when the participant completes the blood draw, and after the participant's cancer status is established (at enrollment for those enrolled with confirmed CRC (Cohort 2), and by 60 days post-colonoscopy for those in the prospective cohort (Cohort 1)). Participants in Cohort 1 may be directly contacted after enrollment if diagnosis details are not available in the medical records. It is expected that study enrollment will take approximately 12 months. Results generated from study samples are investigational and will not be returned to investigators, study participants, or participants' healthcare providers, and will not be used for clinical decision-making.
Interventions
None listed
Sponsors
Harbinger Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cohort 1: Prospective Cohort Inclusion criteria - All Participants must meet the following criteria to be included in the study: 1. Provide written or electronic informed consent, according to local guidelines, signed and dated by the Participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses 2. Age 45 or older at time of consent 3. Documented positive result from a mt-sDNA test obtained as part of routine clinical care within 12 months of blood draw 4. Scheduled and intends to undergo a diagnostic colonoscopy within 60 days of consent as part of standard care 5. Considered by a physician as being of average risk for CRC 6. Willing to provide an investigational blood draw prior to undergoing bowel preparation administration and colonoscopy. * Cohort 2: Confirmed Case Cohort Inclusion criteria - All Participants must meet the following criteria to be included in the study: 1. Provide written or electronic informed consent, according to local guidelines, signed and dated by the Participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses 2. Age 45 or older at time of consent 3. Has a confirmed CRC diagnosis within 90 days prior to signing the informed consent form, based on standard diagnostic procedures 4. Must remain treatment-naïve for the current malignancy (no surgical resection, neoadjuvant chemotherapy, or radiation therapy has occurred since diagnosis)
Exclusion criteria
* Cohort 1: Prospective Cohort
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish predictive value | 14 month | 1\. Establish the predictive value of the Harbinger test for colorectal cancer (CRC) per test readout category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Establish incidence | 14 months | Establish the incidence of CRC (by stage) and advanced adenoma (AA) |
| Establish readout distribution | 14 months | Establish the readout distribution of the Harbinger test for CRC cases (by stage), AA cases, and Participants without CRC or AA. |
Countries
United States
Outcome results
None listed