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

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ClinicalTrials.gov Identifier: NCT04136002
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Health Decisions
Information provided by (Responsible Party):
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.

Condition or disease
Colorectal Cancer

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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2024



Primary Outcome Measures :
  1. Sensitivity of colorectal cancer detection [ Time Frame: 60 days ]
  2. Specificity of advanced neoplasia detection [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Positive predictive value of colorectal cancer detection [ Time Frame: 60 days ]
  2. Negative predictive value of colorectal cancer detection [ Time Frame: 60 days ]
  3. Sensitivity and specificity of advanced adenoma detection [ Time Frame: 60 days ]

Biospecimen Retention:   Samples With DNA
Blood specimens will be retained in order to investigate the performance characteristics of the LUNAR-2 device.


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136002


Contacts
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Contact: Linda Higashi 650-503-1814 ECLIPSE@guardanthealth.com
Contact: Guilnor Afalla Placido 650-503-1814 ECLIPSE@guardanthealth.com

Locations
Show Show 35 study locations
Sponsors and Collaborators
Guardant Health, Inc.
Health Decisions
Investigators
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Principal Investigator: Kathryn Lang, MBBS MRCP GUARDANT HEALTH

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Responsible Party: Guardant Health, Inc.
ClinicalTrials.gov Identifier: NCT04136002    
Other Study ID Numbers: 02-GI-002
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases