To evaluate the consistency and diagnostic accuracy of risk profiles using genetic markers across three different sampling modalities: biopsy, brush sampling, and TOS.
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the diagnostic accuracy (sensitivity and specificity) of genetic
markers in detecting at-risk patients (defined as having a diagnosis of LGD,
HGD, or EAC) across three sampling modalities: biopsy, brush sampling, and TOS*
Secondary outcome
2 To compare the diagnostic accuracy (sensitivity and specificity) of genetic
markers in detecting high-risk patients (defined as having a diagnosis HGD or
EAC) across three sampling modalities: biopsy, brush sampling, and TOS
3 The number and type of genetic markers uniquely detected by each sampling
method and their relative abundance or detection rate in each method.
4. The spatial distribution patterns and detection rates of
progression-associated genetic markers in biopsy, brush sampling, and TOS
samples.
Background summary
: In Western countries, there is a notable increase in the incidence of
esophageal cancer and Barrett's Esophagus (BE). This rising trend underscores
the urgent need for effective surveillance strategies. As advanced screening
technologies become more accessible, a significant number of patients are being
enrolled in surveillance programs. Surveillance is critical, as esophageal
adenocarcinoma (EAC) often has a poor prognosis if diagnosed at an advanced
stage. Early detection through surveillance facilitates timely endoscopic
interventions, significantly reducing mortality and morbidity.
Current endoscopic surveillance methods for BE patients face several
challenges. They are expensive, impose a significant burden on patients, and
are generally not cost-effective. Traditional biopsy-based pathology
assessments, the cornerstone of this strategy, suffer from subjectivity, with
poor inter-pathologist agreement and limited predictive value for assessing
progression risks. Additionally, the focal nature of neoplasia in the esophagus
means that biopsies can miss localized lesions due to their limited sampling
scope.
It is suggested that employing broad-area sampling with a brushing technique as
a supplemental method potentially enhances the detection rates of neoplastic
changes in BE. However both brushing and traditional methods still necessitate
costly invasive endoscopic procedures. As an innovative step forward, the
transoral sampling (TOS) 'pill-on-a-string' device is designed to sample the
entire circumference of the esophagus non-invasively. This method could
significantly shift current surveillance paradigms by providing comprehensive
and patient-friendly approaches, although it still lacks adequate risk
stratification tools.
Recent developments in genetic profiling have introduced promising tools for
enhancing BE surveillance. Genetic markers has revealed specific patterns that
may be pivotal in predicting the progression from Non Dysplastic Barrett's
Esophagus (NDBE) to esophageal adenocarcinoma. These markers hold potential not
only for improving diagnostic accuracy but also for stratifying patients
according to their risk levels. By employing a comprehensive genetic panel,
surveillance methods could shift from invasive procedures to more
patient-friendly approaches.
This study aims to validate these genetic markers across different sampling
modalities, focusing on their ability to consistently stratify risk and detect
early neoplastic changes, and to integrate them into an optimal panel for use
with the 'pill-on-a-string' TOS device. By assessing these markers across
different sampling modalities, this research seeks to demonstrate their
potential in streamlining BE surveillance, reducing invasiveness, and enhancing
cost-effectiveness.
Study objective
To evaluate the consistency and diagnostic accuracy of risk profiles using
genetic markers across three different sampling modalities: biopsy, brush
sampling, and TOS.
Study design
This is a multicenter, prospective cohort observational study.
Study burden and risks
In this study, patients with Barrett's esophagus undergo standard endoscopic
evaluations, supplemented with additional tissue sampling methods such as the
"pill-on-a-string" (PoS) and brush sampling. These extra procedures add minimal
burden since they are performed during already scheduled endoscopies. For some
patients, an additional visit is required for a second PoS sampling. The risks
associated with these procedures are low; the most common side effect is a
temporary sore throat. In rare instances, the PoS pill may detach, but this can
be easily managed with a follow-up endoscopy. Overall, the extra burden and
risks for participants are negligible.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Patients age: >= 18 years
- BE with a maximal extent of >=1cm
- Willingness to undergo an esophagogastroduodenoscopy (EGD) with sampling
using a pill-on-a-string device.
- Willingness to undergo an trans oral sampling procedure with a pill on the
string device
- Cohort 1: Barrett's Esophagus (BE) patients who, within 18 months before or
during the baseline endoscopy, have the worst grade pathology diagnosis of
High-Grade Dysplasia (HGD) or Esophageal Adenocarcinoma (EAC), or present a
visible lesion suspected of neoplasia.
- Cohort 2: Barrett's Esophagus (BE) patients who, within 18 months before or
during the baseline endoscopy, have the worst grade pathology diagnosis of
Low-Grade Dysplasia (LGD).
- Cohort 3: Barrett's Esophagus (BE) patients who, within 18 months before or
during the baseline endoscopy, show no evidence of dysplasia
- Ability to give written, informed consent and understand the responsibilities
of participation
Exclusion criteria
• Patients within eight weeks after endoscopy with biopsies and/or ER
• History of esophageal or gastric surgery other than fundoplication
• History of endoscopic treatment for neoplasia in the esophagus or stomach.
• History of esophageal ablation or dilation therapy
• Presence of esophageal varices and/or suspected portal hypertension during
imaging endoscopy at baseline
• Present Dysphagia/ swallowing disorders at the time of screening and
participation
• Pregnancy
• Patients with known or suspected anatomical abnormalities of the esophagus or
stomach
• Patients taking anti-thrombotic drugs that cannot be temporarily discontinued
• Subject has a known history of unresolved drug or alcohol dependency that
would limit ability to comprehend or follow instructions related to informed
consent, post-treatment instructions, or follow-up guidelines
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87263.018.24 |