Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06693622

Conditions

Gastro Esophageal Reflux Disease

Barrett Esophagus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Patient survey

Study Details

Brief summary:

This study plans to learn more about what patients think about screening for esophageal cancer (EAC) and Barrett's esophagus (BE); a pre-cancerous condition associated with esophageal cancer. The plan is to use this information to modify screening practices in the United States with the goal to decrease the number of people who die from esophageal cancer.

Conditions

Gastro Esophageal Reflux Disease

Barrett Esophagus

Study ID

NCT06693622

Start date

Nov 1, 2024

Status verified date

Nov, 2024

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Provision to sign and date the consent form.
  • Stated willingness to comply with all study procedures and be available for the duration of the study.
  • Individual has 3 or more established risk factors for BE (age > 50 years, chronic GERD, male, white race, smoking, obesity, family history of BE/EAC).

Exclusion Criteria:

  • Unable to consent.
  • Prior diagnosis of BE/EAC.
  • Life limiting comorbidity/ disability.
  • Active dementia/ cognitive impairment.
  • Incarcerated.

Study Design

Enrollment

556 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients

556 eligible patients will be recruited across 5 participating sites to complete a discrete choice-based conjoint survey. The survey will be distributed to eligible patients via Sawtooth internet survey at the time of a clinic appointment or remotely via video chat.

Interventions

Patient survey

To assess patient preferences and barriers for attributes of BE/EAC screening modalities patients will complete a survey evaluating 5 domains: benefit of detection (sensitivity), convenience (time, setting), screening related physical harms (procedural discomfort), and financial harms. Prior to distribution, the survey will be refined and pretested among a sample of 5 patients.

Primary outcome measure

  • Define patient preferred BE/EAC screening test and barriers for attributes of BE/EAC screening tests [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Alexa DeBord, MS

303-724-0432alexa.debord@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Alexa DeBord, MS

303-724-0432alexa.debord@cuanschutz.edu

Principal Investigator:

Sachin Wani, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 18, 2024

Last verified

Nov, 2024

Keywords

  • Gastroesophageal Reflux Disease
  • Barrett's Esophagus
  • Barrett's Esophagus Screening
  • BE
  • GERD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-11-18.