Early detection of Barrett's esophagus and esophageal cancer: accuracy and acceptability of a novel screening strategy in primary care.

Early detection of Barrett's esophagus and esophageal cancer: accuracy and acceptability of a novel screening strategy in primary care. - Early detection Barrett's esophagus and esophageal cancer in primary care.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49567

Enrollment

450

Registered

2020-11-23

Start date

2021-04-20

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's esophagus esophageal adenocarcinoma Esophageal cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - Upper endoscopy in the previous 5 years; - A current or previous diagnosis of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC)); - Already known with a diagnosis of Barrett*s esophagus; - Any argument provided by a patient*s own general practitioner not to include the patient; - Comorbidities precluding transnasal endoscopy (e.g. inability to discontinue oral anticoagulants, history of recurrent epistaxis, allergy to lidocaine derivatives).

Design outcomes

Primary

Measure	Time frame
Main study parameter / endpoint: accuracy (PPV, NPV, sensitivity, and specificity) of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care. Gold standard: transnasal endoscopy and upper endoscopy.	—

Secondary

Measure	Time frame
Secondary study parameters / endpoints: - Patient acceptability of the eNose, the uTNE and if applicable the upper endoscopy (i.e. test experience) (directly after procedure) - Willingness to undergo repeat procedure (directly after procedure) - CWS-8 (at baseline, 7 days and 30 days after procedure and 90 days after the last study procedure (i.e. uTNE or if applicable the upper endoscopy)) - STAI-6 (at baseline, 7 days and 30 days after procedure and 90 days after the last study procedure (i.e. uTNE or if applicable the upper endoscopy)) - IES-15 (7 days and 30 days after procedure and 90 days after the last study procedure (i.e. uTNE or if applicable the upper endoscopy)) - Endoscopic findings, procedure yield, defined as the proportion of patients found to have Barretts esophagus or (early stage) esophageal cancer, or another finding - Rate of successful intubation and complete evaluation by uTNE - Safety of the eNose breath test and uTNE (Adverse Events) - Reproducibility of a positive breath test - Number of confirmed diagnoses of Barretts esophagus (defined as >1cm of columnar metaplasia combined with the presence of intestinal metaplasia on biopsies) - Rate and quality of successful biopsies taken by uTNE (number, size, and quality of biopsies sufficient for histologic diagnosis) Other study parameters: Demographics: gender, age, civil status, employment status, social status, BMI, waist circumference. General medical history: hypertension, cardiovascular, pulmonary, hepatic, diabetes, GERD symptoms, malignancies, infectious diseases and medication use (including heartburn medication). Alarm symptoms: hematemesis, melena, weight loss, fever. Lifestyle factors: tobacco use, alcohol use, physical activity, diet. Endoscopic and histologic diagnosis: Prague classification (length of BE), presence of esophagitis, hiatal hernia or dysplasia, other conditions. Family history: number of first-grade relatives with BE or EAC. Test char	—

Measure

Time frame

Secondary study parameters / endpoints: - Patient acceptability of the eNose, the uTNE and if applicable the upper endoscopy (i.e. test experience) (directly after procedure) - Willingness to undergo repeat procedure (directly after procedure) - CWS-8 (at baseline, 7 days and 30 days after procedure and 90 days after the last study procedure (i.e. uTNE or if applicable the upper endoscopy)) - STAI-6 (at baseline, 7 days and 30 days after procedure and 90 days after the last study procedure (i.e. uTNE or if applicable the upper endoscopy)) - IES-15 (7 days and 30 days after procedure and 90 days after the last study procedure (i.e. uTNE or if applicable the upper endoscopy)) - Endoscopic findings, procedure yield, defined as the proportion of patients found to have Barrett*s esophagus or (early stage) esophageal cancer, or another finding - Rate of successful intubation and complete evaluation by uTNE - Safety of the eNose breath test and uTNE (Adverse Events) - Reproducibility of a positive breath test - Number of confirmed diagnoses of Barrett*s esophagus (defined as >1cm of columnar metaplasia combined with the presence of intestinal metaplasia on biopsies) - Rate and quality of successful biopsies taken by uTNE (number, size, and quality of biopsies sufficient for histologic diagnosis) Other study parameters: Demographics: gender, age, civil status, employment status, social status, BMI, waist circumference. General medical history: hypertension, cardiovascular, pulmonary, hepatic, diabetes, GERD symptoms, malignancies, infectious diseases and medication use (including heartburn medication). Alarm symptoms: hematemesis, melena, weight loss, fever. Lifestyle factors: tobacco use, alcohol use, physical activity, diet. Endoscopic and histologic diagnosis: Prague classification (length of BE), presence of esophagitis, hiatal hernia or dysplasia, other conditions. Family history: number of first-grade relatives with BE or EAC. Test char

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Countries

Netherlands

Outcome results