NCT04656392Completed
Early Detection of Barrett's Esophagus in Participants With Reflux Symptoms in Primary Care
Early Detection of Barrett's Esophagus and Esophageal Cancer: Accuracy and Acceptability of a Novel Screening Strategy in Primary Care
Source: ClinicalTrials.gov · Last updated 16 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In the Netherlands, the incidence of esophageal adenocarcinoma (EAC) is increasing. In addition, EAC has a dismal prognosis. Therefore, screening for Barrett's Esophagus (BE) has stimulated interest. Although BE is a known precursor of EAC, a minority of patients with EAC are known with a previous diagnosis of BE. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 449 (actual)
- First submitted
- 30 Nov 2020
- Start date
- 20 Apr 2021
- Primary completion date
- 11 Mar 2024
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04656392
What you commit to
- Study type: Interventional
- Participants enrolled: 449
- From 20 Apr 2021 to the primary completion date, 11 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Upper endoscopy in the previous 5 years;
- A current or previous diagnosis and/or treatment of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC)) within the last five years;
Other illness
- Already known with a diagnosis of Barrett's esophagus or gastro-esophageal cancer;
- Comorbidities precluding transnasal endoscopy (e.g. inability to discontinue oral anticoagulants, history of recurrent epistaxis, allergy to lidocaine derivatives).
Other
- Any argument provided by a patient's own general practitioner not to include the patient;
Who the study is looking for
- Patient aged 50 to 75 years;
- Recorded diagnosis of reflux symptoms \>90 days OR
- Recorded prescriptions for acid suppressant therapy for this indication for at least 1 year in the past 5 years
- Written informed consent.
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.