To assess the feasibility and safety of using a combined sponge-methylation biomarker strategy in detection of Barrett*s Esophagus, (early) esophageal cancer and detection of locoregional regrowth after nCRT.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the accuracy (defined as sensitivity and specificity) of diagnosis
with the EsophaCap sponge and an assay of selected methylated markers
Secondary outcome
To assess the accuracy, safety and tolerability of the combined
sponge-methylation biomarker strategy; including the rate of successful
retrievals of the EsophaCap (defined as retrieval of the complete EsophaCap
sponge, from the stomach back into the mouth), the extracted DNA yield, a
mucosal injury score, a tolerability assessment, and the preference of patients
in relation to upper endoscopy.
Background summary
Esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESCC)
are associated with a very poor 5 year survival rate of less than 20%. Early
detection is highly desirable since it is associated with improved survival
rates. Conventional endoscopy with biopsy remains the standard procedure for
early detection of esophageal cancer in patients at risk for malignant
progression, such as in patients with Barrett*s esophagus (BE) and esophageal
atresia (EA). Furthermore, timely detection of locoregional esophageal cancer
regrowth is important for patients who undergo active surveillance after
neoadjuvant chemoradiotherapy (nCRT). In all these patients, endoscopies have
impact on patients* burden and endoscopy capacity. Furthermore, the
cost-effectiveness of these procedures is uncertain.
Overall, there is an urgent need to develop other surveillance methods for
detection of early esophageal cancer and detection of locoregional disease
after nCRT. Esophageal cytology devices, such as the EsophaCap, have been
studied as a non-endoscopic way to detect esophageal cancer. The EsophaCap is a
non-invasive device that comprises a small sponge-containing capsule on a
string, which is swallowed by the patient. After contact with the stomach the
capsule dissolves and releases the sponge, which is then retrieved along the
esophagus and collects cytologic material from the esophageal mucosa. This
cytologic material is then available for diagnostic analyses. Studies have
shown that methylation biomarkers can be used to detect Barrett*s Esophagus
(BE), high-grade dysplasia (HGD), and both EAC and ESCC. Applying the use of
methylation biomarkers on cytological material provided by the EsophaCap may
allow effective surveillance of BE and early detection of esophageal cancer,
but such approaches must be accurate, well-tolerated and safe.
Study objective
To assess the feasibility and safety of using a combined sponge-methylation
biomarker strategy in detection of Barrett*s Esophagus, (early) esophageal
cancer and detection of locoregional regrowth after nCRT.
Study design
Interventional prospective pilot study.
Study burden and risks
Data are collected during one visit, there is no follow-up. Patients will
swallow the EsophaCap immediately prior to their scheduled upper endoscopy.
After this procedure, participants will be asked to fill in a short
questionnaire. Previous studies show that there are minimal risks to using the
EsophaCap. The main burden for patients includes discomfort while swallowing
the device, but an excellent overall median tolerability score of 2 (on a scale
of 0-10, where 0 is extremely well tolerated and 10 is the worst tolerated) was
observed in a previous study with Barrett patients. If the string is
accidentally cut, the sponge will not cause any harm to the patient since the
sponge can be removed during upper endoscopy or, if removal is unsuccessful,
will naturally be excreted with the faeces. The results from the EsophaCap
study will not be shared with the patient nor their treating physician.
Therefore, the outcomes of the EsophaCap procedure will not have any effect on
treatment or surveillance strategies. Treatment and follow-up of patients will
not differ from patients who are not enrolled in this study.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a subject must meet all of the
following criteria:
* Diagnosed with esophageal atresia OR Barrett*s Esophagus OR newly diagnosed
esophageal cancer OR patients with locally advanced esophageal cancer who are
in active surveillance after nCRT.
* Undergo endoscopic surveillance with biopsies at the Erasmus University
Medical Center.
* Age above 18 years.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* Patients with difficulties swallowing medication or with eating solid foods
* Patients with a nasogastric tube.
* Patients with esophageal strictures disabling passage of the capsule.
* Patients with esophageal stents.
* Patients who have undergone esophagectomy.
* Patients with extra-esophageal malignancies including head, neck and gastric
cancer.
Design
Recruitment
Medical products/devices used
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 | NL77979.078.22 |