Barrett EsophagusLucid RegistryNCT05965999
Lucid Registry Study
An observational study of Barrett Esophagus and Esophageal Adenocarcinoma, run by Lucid Diagnostics, Inc. at 1 site in United States.
Trial summary
This is a multicenter, prospective, observational study designed to capture a limited set of data consisting of diagnostic test results and clinical management information on subjects who undergo EC/EG to assess for the presence of BE/EAC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia
- What is being tested?
- EsoCheck® and EsoGuard®
- Type of treatment
- Medical device
- How many people
- 8,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 31 Dec 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who have recently undergone or are scheduled to undergo EsoCheck administration (as prescribed by a licensed healthcare provider) will be invited to participate in the optional EsoGuard Registry.
Who may be able to join
- Individuals in whom a healthcare provider has made the independent clinical decision to screen for BE/EAC (based on assessment of elevated disease risk) using EsoGuard for analysis of cell samples collected with EsoCheck
- Provided written informed consent for prospective registry participation/data collection
Who cannot join
- Inability to provide written informed consent
- Subjects who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sr. Director contact
United States1 site, 1 recruiting
- Recruiting
LUCID DX
Lake Forest, California, 92630
Lucid Dx Labs, 888-582-4339, info@LucidDx.com
About this study
Official title: A Multicenter, Prospective, Open-Label Registry Study of the Utilization of EsoGuard, on Samples Collected Using EsoCheck, in an At-Risk Population Undergoing Standard of Care Screening for, and Management of, Previously Undiagnosed Barrett's Esophagus and/or Esophageal Adenocarcinoma
This is a multicenter, prospective, observational study designed to capture a limited set of data consisting of diagnostic test results and clinical management information on subjects who undergo EC/EG to assess for the presence of BE/EAC. Once sufficient time has elapsed for EsoGuard results to be available, as well as for any subsequent clinical evaluation to have been performed (e.g., upper endoscopy and any initial therapeutic management), study staff will obtain the desired information and record it in an electronic data collection (EDC) system, pertaining to subject demographics, pertinent medical history, and risk factors for BE or EAC as well as (1) information about the EsoCheck cell collection procedure and patient tolerance, (2) EsoGuard test result; (3) initial clinical management including upper endoscopy, if performed, and diagnosis (as determined by the endoscopist and the pathologist assessing any biopsies taken.
For subjects endoscopically confirmed with intestinal metaplasia, dysplasia, or cancer, the registry will collect additional clinical management and/or a therapeutic procedure(s) performed and other mid- to long-term outcomes.
Read more
For subjects who are negative for BE/EAC via EsoGuard or negative for BE/EAC via EGD will be offered the option of longer-term follow-up in the form of intermittent wellness checks.
The time point for collecting such information shall be fluid, depending on the time course of care provided subsequent to the EsoGuard result being available. Subject participation duration is dependent on EsoGuard results, physician referral, EGD results (if referred) and participation in long-term follow-up. If EG results are negative and subject is not referred for an EGD, participation could last 1 month. If a subject is confirmed with BE/EAC, participation may continue beyond this minimum for an indefinite period, with no predetermined maximum duration.
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia
- Being tested
- EsoCheck®, EsoGuard®
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsoCheck®Device
EsoCheck® (EC) is an FDA 510(k) cleared device that is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population 12 years of age and older.
EsoGuard®Diagnostic test
EsoGuard® is a DNA assay which examines for the presence of cytosine methylation at 31 different genomic locations on the vimentin (VIM) and Cyclin-A1 (CCNA1) genes. Using EsoCheck and EsoGuard in combination may offer an accurate, lower cost, non-invasive, approach to screen for Barrett's Esophagus (BE) with and without dysplasia, and for esophageal adenocarcinoma (EAC).
What is being measured
The primary outcome is the main question the study is designed to answer.
Subsequent Clinical Management Following EsoGuard Testing
Proportion of subjects who undergo a clinically relevant management action following receipt of an EsoGuard result, including referral for esophagogastroduodenoscopy (EGD), surveillance, therapeutic intervention, or other physician-directed management. Clinical management decisions are collected as part of routine clinical care.
Measured: Up to 12 months following EsoGuard testing
Secondary outcomes (6)
Endoscopic Confirmation of Barrett's Esophagus and/or Esophageal Neoplasia
Proportion of subjects with a completed EGD and pathology assessment confirming Barrett's esophagus (BE), dysplasia, esophageal adenocarcinoma (EAC), or other relevant esophageal findings following EsoGuard testing.
Measured: Up to 12 months following EsoGuard testing
Disease Stage at Endoscopic Diagnosis
Histologic and/or clinical stage of Barrett's esophagus, dysplasia, or esophageal neoplasia identified during clinically indicated endoscopic evaluation following EsoGuard testing.
Measured: Up to 12 months following EsoGuard testing
Therapeutic Interventions Following EsoGuard Testing
Proportion of subjects who undergo therapeutic intervention for BE, dysplasia, or EAC, including endoscopic eradication therapy, surgical intervention, pharmacologic treatment, or other standard-of-care management.
Measured: Up to 12 months following EsoGuard testing
Surveillance Utilization Following EsoGuard Testing
Proportion of subjects who undergo follow-up surveillance procedures or monitoring for BE/EAC according to routine clinical practice.
Measured: Up to 24 months following EsoGuard testing
Incident Detection of Barrett's Esophagus or Esophageal Adenocarcinoma
Number and proportion of subjects initially considered negative for BE/EAC who subsequently receive a diagnosis of BE, dysplasia, or EAC during follow-up.
Measured: Up to 24 months following EsoGuard testing
Disease Progression or Resolution
Among subjects with identified esophageal disease, assessment of disease progression, stability, or resolution based on available endoscopic, histologic, and clinical follow-up data.
Measured: Up to 24 months following EsoGuard testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start11 Apr 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Lucid Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victoria Lee, MD, Study chair, Lucid Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965999
- Sponsor's protocol ID
- LUD-PR-0421
- Acronym
- Lucid Registry
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Open-Label Registry Study of the Utilization of EsoGuard, on Samples Collected Using EsoCheck, in an At-Risk Population Undergoing Standard of Care Screening for, and Management of, Previously Undiagnosed Barrett's Esophagus and/or Esophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05965999
- Acronym / sponsor ID
- Lucid Registry / LUD-PR-0421
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Lucid Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, prospective, observational study designed to capture a limited set of data consisting of diagnostic test results and clinical management information on subjects who undergo EC/EG to assess for the presence of BE/EAC. Once sufficient time has elapsed for EsoGuard results to be available, as well as for any subsequent clinical evaluation to have been performed (e.g., upper endoscopy and any initial therapeutic management), study staff will obtain the desired information and record it in an electronic data collection (EDC) system, pertaining to subject demographics, pertinent medical history, and risk factors for BE or EAC as well as (1) information about the EsoCheck cell collection procedure and patient tolerance, (2) EsoGuard test result; (3) initial clinical management including upper endoscopy, if performed, and diagnosis (as determined by the endoscopist and the pathologist assessing any biopsies taken.
For subjects endoscopically confirmed with intestinal metaplasia, dysplasia, or cancer, the registry will collect additional clinical management and/or a therapeutic procedure(s) performed and other mid- to long-term outcomes.
For subjects who are negative for BE/EAC via EsoGuard or negative for BE/EAC via EGD will be offered the option of longer-term follow-up in the form of intermittent wellness checks.
The time point for collecting such information shall be fluid, depending on the time course of care provided subsequent to the EsoGuard result being available. Subject participation duration is dependent on EsoGuard results, physician referral, EGD results (if referred) and participation in long-term follow-up. If EG results are negative and subject is not referred for an EGD, participation could last 1 month. If a subject is confirmed with BE/EAC, participation may continue beyond this minimum for an indefinite period, with no predetermined maximum duration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who have recently undergone or are scheduled to undergo EsoCheck administration (as prescribed by a licensed healthcare provider) will be invited to participate in the optional EsoGuard Registry.
Key inclusion criteria (2 listed)
- Individuals in whom a healthcare provider has made the independent clinical decision to screen for BE/EAC (based on assessment of elevated disease risk) using EsoGuard for analysis of cell samples collected with EsoCheck
- Provided written informed consent for prospective registry participation/data collection
Key exclusion criteria (2 listed)
- Inability to provide written informed consent
- Subjects who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsoCheck®EsoCheck® (EC) is an FDA 510(k) cleared device that is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population 12 years of age and older. | Device | – |
| EsoGuard®EsoGuard® is a DNA assay which examines for the presence of cytosine methylation at 31 different genomic locations on the vimentin (VIM) and Cyclin-A1 (CCNA1) genes. Using EsoCheck and EsoGuard in combination may offer an accurate, lower cost, non-invasive, approach to screen for Barrett's Esophagus (BE) with and without dysplasia, and for esophageal adenocarcinoma (EAC). | Diagnostic test | – |
Primary outcome
Subsequent Clinical Management Following EsoGuard Testing
Time frame: Up to 12 months following EsoGuard testing
Proportion of subjects who undergo a clinically relevant management action following receipt of an EsoGuard result, including referral for esophagogastroduodenoscopy (EGD), surveillance, therapeutic intervention, or other physician-directed management. Clinical management decisions are collected as part of routine clinical care.
6 secondary outcomes
Endoscopic Confirmation of Barrett's Esophagus and/or Esophageal Neoplasia
Time frame: Up to 12 months following EsoGuard testing
Disease Stage at Endoscopic Diagnosis
Time frame: Up to 12 months following EsoGuard testing
Therapeutic Interventions Following EsoGuard Testing
Time frame: Up to 12 months following EsoGuard testing
Surveillance Utilization Following EsoGuard Testing
Time frame: Up to 24 months following EsoGuard testing
Incident Detection of Barrett's Esophagus or Esophageal Adenocarcinoma
Time frame: Up to 24 months following EsoGuard testing
Disease Progression or Resolution
Time frame: Up to 24 months following EsoGuard testing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sr. Director contact
Victoria Lee, MD study chair
Lucid Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus and Esophageal Adenocarcinoma, run by Lucid Diagnostics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Project Manager (917-813-1828, axr@pavmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subsequent Clinical Management Following EsoGuard Testing (time frame: Up to 12 months following EsoGuard testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.