Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode

Active, not recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT04136002
• Lead Sponsor: Guardant Health, Inc.

Brief Summary

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.

Detailed Description

The LUNAR-2 test has been developed to detect malignant disease in screen-relevant patients who would otherwise undergo screening for malignant disease using invasive methodologies such as colonoscopy. The intended use of such a test would be to return a result of ctDNA detected/ ctDNA not detected in a patient eligible for average risk screening for colorectal cancer. Those patients who receive a ctDNA detected result should undergo further investigation with colonoscopy.

In order to define the performance characteristics of the test in a relevant population, this study will perform a blood draw prior to the patient undergoing the standard of care colonoscopy (and all associated preparatory medications) and retrospectively compare the performance characteristics of the LUNAR-2 test with the findings of the index colonoscopy.

Outcomes of patients at one and two-years post-procedure will be collected as secondary endpoints to investigate the possibility of incidental, non-colorectal cancer cases and interval cancers that had not reached the clinical threshold for detection at the time of the index colonoscopy.

Study Timeline

• Study Start: 2019-10-08
• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Primary Completion: 2024-03-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44467

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of colorectal cancer detection	60 days	Sensitivity of colorectal cancer detection
Specificity of advanced neoplasia detection	60 days	Specificity of advanced neoplasia detection

Secondary Outcome Measures

Name	Time	Method
Negative predictive value of colorectal cancer detection	60 days	Negative predictive value of colorectal cancer detection
Positive predictive value of colorectal cancer detection	60 days	Positive predictive value of colorectal cancer detection
Sensitivity and specificity of advanced adenoma detection	60 days	Sensitivity and specificity of advanced adenoma detection

Trial Locations

Locations (253)

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; 🇺🇸 Glendale, Arizona, United States

Southeast Valley Gastroenterology; 🇺🇸 Chandler, Arizona, United States

Prime Medical Group, LLC; 🇺🇸 Gilbert, 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

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