Jasper, Alabama 35501

  • Colorectal Cancer

Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

02-GI-002


NCT ID:

NCT04136002


Secondary ID:


Study Acronym:

ECLIPSE


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

45 Years


Maximum Age:

84 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Guardant Health, Inc.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

20000


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Craig Eagle, MD
Principal Investigator
GUARDANT HEALTH
Primary Contact:Erika Vento-Gaudens, MBA
707-342-8691
egaudens@guardanthealth.com
Backup Contact:Guilnor Afalla Placido
650-503-1814
ECLIPSE@guardanthealth.com

Study Dates

Start Date:October 8, 2019
Completion Date:January 1, 2024
Completion Type:Anticipated
Primary Completion Date:November 1, 2022
Primary Completion Type:Anticipated
Verification Date:June 2022
Last Changed Date:June 17, 2022
First Received Date:October 21, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Sensitivity of colorectal cancer detection
Time Frame:60 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Specificity of advanced neoplasia detection
Time Frame:60 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Positive predictive value of colorectal cancer detection
Time Frame:60 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Negative predictive value of colorectal cancer detection
Time Frame:60 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Sensitivity and specificity of advanced adenoma detection
Time Frame:60 days
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Guardant Health, Inc.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Premier Research Group plc

Samples and Retentions

Sample Retention:Samples With DNA
Description: Blood specimens will be retained in order to investigate the performance characteristics of the LUNAR-2 device.
Study Population: Single cohort of patients aged between 45 and 84, with no known high risk features, undergoing routine colorectal cancer screening as standard of care.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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