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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04136002
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : March 15, 2021
Health Decisions
Information provided by (Responsible Party):
Guardant Health, Inc.

Tracking Information
First Submitted Date October 21, 2019
First Posted Date October 23, 2019
Last Update Posted Date March 15, 2021
Actual Study Start Date October 8, 2019
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2019)
  • Sensitivity of colorectal cancer detection [ Time Frame: 60 days ]
  • Specificity of advanced neoplasia detection [ Time Frame: 60 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 21, 2019)
  • Positive predictive value of colorectal cancer detection [ Time Frame: 60 days ]
  • Negative predictive value of colorectal cancer detection [ Time Frame: 60 days ]
  • Sensitivity and specificity of advanced adenoma detection [ Time Frame: 60 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Blood specimens will be retained in order to investigate the performance characteristics of the LUNAR-2 device.
Sampling Method Non-Probability Sample
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.
Condition Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 21, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2024
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sexes Eligible for Study: All
Ages 45 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contact: Linda Higashi 650-503-1814
Contact: Guilnor Afalla Placido 650-503-1814
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT04136002
Other Study ID Numbers 02-GI-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Guardant Health, Inc.
Study Sponsor Guardant Health, Inc.
Collaborators Health Decisions
Principal Investigator: Kathryn Lang, MBBS MRCP GUARDANT HEALTH
PRS Account Guardant Health, Inc.
Verification Date March 2021