Lucid-Registrierungsstudie (Lucid Registry)
Eine multizentrische, prospektive, offene Registerstudie zur Verwendung von EsoGuard an mit EsoCheck gesammelten Proben in einer Risikopopulation, die sich einem standardmäßigen Screening und Management von zuvor nicht diagnostiziertem Barrett-Ösophagus und/oder Ösophagus-Adenokarzinom unterzieht
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Study Project Manager
- Telefonnummer: 917-813-1828
- E-Mail: axr@pavmed.com
Studieren Sie die Kontaktsicherung
- Name: Sr. Director
- E-Mail: gxl@pavmed.com
Studienorte
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California
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Lake Forest, California, Vereinigte Staaten, 92630
- Rekrutierung
- LUCID DX
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Kontakt:
- Lucid Dx Labs
- Telefonnummer: 888-582-4339
- E-Mail: info@LucidDx.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to provide written informed consent
- Subjects who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Subsequent Clinical Management Following EsoGuard Testing
Zeitfenster: Up to 12 months following EsoGuard testing
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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. |
Up to 12 months following EsoGuard testing
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Endoscopic Confirmation of Barrett's Esophagus and/or Esophageal Neoplasia
Zeitfenster: Up to 12 months following EsoGuard testing
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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. |
Up to 12 months following EsoGuard testing
|
|
Disease Stage at Endoscopic Diagnosis
Zeitfenster: Up to 12 months following EsoGuard testing
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Histologic and/or clinical stage of Barrett's esophagus, dysplasia, or esophageal neoplasia identified during clinically indicated endoscopic evaluation following EsoGuard testing. |
Up to 12 months following EsoGuard testing
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Therapeutic Interventions Following EsoGuard Testing
Zeitfenster: Up to 12 months following EsoGuard testing
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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. |
Up to 12 months following EsoGuard testing
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|
Surveillance Utilization Following EsoGuard Testing
Zeitfenster: Up to 24 months following EsoGuard testing
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Proportion of subjects who undergo follow-up surveillance procedures or monitoring for BE/EAC according to routine clinical practice. |
Up to 24 months following EsoGuard testing
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Incident Detection of Barrett's Esophagus or Esophageal Adenocarcinoma
Zeitfenster: Up to 24 months following EsoGuard testing
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Number and proportion of subjects initially considered negative for BE/EAC who subsequently receive a diagnosis of BE, dysplasia, or EAC during follow-up. |
Up to 24 months following EsoGuard testing
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Disease Progression or Resolution
Zeitfenster: Up to 24 months following EsoGuard testing
|
Among subjects with identified esophageal disease, assessment of disease progression, stability, or resolution based on available endoscopic, histologic, and clinical follow-up data. |
Up to 24 months following EsoGuard testing
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Victoria Lee, MD, Lucid Diagnostics
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LUD-PR-0421
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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