Condition: Colorectal Cancer · Sponsor: Guardant Health, Inc.
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
The ECLIPSE (Evaluation of the ctDNA LUNAR test in an Average Patient Screening Episode) study is a prospective, observational multi-site study without randomization. The primary objective of the study is to evaluate the performance characteristics of a blood-based ctDNA LUNAR-2 test to detect colorectal cancer in a screen-relevant, average risk population.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: 1. Subjects aged 45-84 years at time of consent 2. Intended to undergo screening colonoscopy 3. Considered by a physician or healthcare provider as being of 'average risk' for CRC 4. Willing to consent to blood draw pre-bowel preparation administration prior to undergoing colonoscopy within 60 days of the date of the investigational blood draw 5. Willing to consent to follow-up for two years as per protocol Exclusion Criteria: 1. Undergoing colonoscopy for investigation of symptoms 2. Has undergone colonoscopy within preceding 9 years 3. Positive FIT/FOBT result within the previous 6 months 4. Has completed Cologuard or Epi proColon testing within the previous 3 years 5. History of colorectal cancer 6. History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study) 7. Known diagnosis of inflammatory bowel disease 8. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs) 9. Positive family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age 10. Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\]) 11. Any major physical trauma (e.g. disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent 12. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study 13. Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Pinnacle Research Group, LLC | Anniston, Alabama, United States | — |
| Lakeview Clinical Research | Guntersville, Alabama, United States | — |
| Medical Affiliated Research Center | Huntsville, Alabama, United States | — |
| Jasper Summit Research LLC | Jasper, Alabama, United States | — |
| Hope Research Institute | Chandler, Arizona, United States | — |
| Southeast Valley Gastroenterology | Chandler, Arizona, United States | — |
| Prime Medical Group, LLC | Gilbert, Arizona, United States | — |
| Hope Research Institute | Glendale, Arizona, United States | — |
| GI Research Associates, LLC | Phoenix, Arizona, United States | — |
| "Forty-Third Medical Associates Absolute Clinical Research" | Phoenix, Arizona, United States | — |
| Del Sol Research Management, LLC | Tucson, Arizona, United States | — |
| Novak Clinical Research | Tucson, Arizona, United States | — |
+ 259 more locations — full list on the registry record.
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