Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06418516 |
| Other study ID # |
439/2023 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
June 1, 2027 |
Study information
| Verified date |
January 2024 |
| Source |
Centre of Postgraduate Medical Education |
| Contact |
Wladyslaw Januszewicz, M.D., PhD |
| Phone |
+48225462328 |
| Email |
wjanuszewicz[@]cmkp.edu.pl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Esophageal squamous cell carcinoma accounts for ~90% of the nearly half-million annual
incident cases of esophageal cancer worldwide. The high costs and invasiveness of upper
endoscopy constitute a limitation in providing adequate surveillance for at-risk individuals,
including those with previous head and neck cancer. The ANGELA study is a prospective
evaluation of the minimally-invasive capsule-sponge device, coupled with tissue biomarkers
(p53-immunohistochemistry), to detect squamous neoplasia in high-risk individuals.
Description:
Esophageal squamous cell carcinoma (ESCC) is the most common type of esophageal cancer
worldwide, accounting for nearly 90% of the 456,000 incident cases of esophageal cancer each
year. Overall, it is the seventh most common malignancy and the sixth most common cause of
cancer-related mortality, with a high incidence rate in eastern to central Asia and eastern
and southern Africa. This cancer is more common in men (~70%), and the main risk factors
include cigarette smoking, alcohol consumption, poor oral hygiene, the ingestion of caustic
agents, and nutritional deficiencies. Additionally, an increased risk of ESCC following
curative treatment of head and neck cancer (HNC) has been well-documented in the literature,
with a lifetime incidence ranging between 3.8% and 14.9% in prospective observational
studies. The carcinogenesis of ESCC is sequential and preceded by several precancerous
stages, including low-grade intraepithelial neoplasia (LG-IEN) and, subsequently, high-grade
intraepithelial neoplasia (HG-IEN).
Although the prognosis of ESCC is extremely poor, with 5-year survival below 20%, it
dramatically improves if the disease is detected at an early stage. Consequently, mass
screening in high-incidence regions is being widely debated. However, population-wide
screening presents a large challenge in terms of cost-effectiveness and manpower, as
currently, a potential screening regime for ESCC would rely on endoscopic examination with
biopsies, which remains the gold standard for ESCC diagnosis. Furthermore, since around 80%
of all ESCCs occur in economically less-developed regions, newer, cheaper, and less invasive
diagnostic tools are highly warranted.
The capsule-sponge is a novel, minimally-invasive device that collects cells from the
esophagus to produce a pseudo-biopsy suitable for routine laboratory analysis. In addition,
tissue biomarkers such as p53 immunohistochemistry (p53-IHC) and molecular testing, including
copy number assays to detect aneuploidy, can be applied. There is extensive data on the use
of this technology for early diagnosis of Barrett's esophagus (precursor to adenocarcinoma),
which has now reached wide clinical implementation in the UK National Health Service.
Building on the promising pilot data, the current study aims to expand further our previously
developed clinical assay for early detection of esophageal squamous neoplasia using the
capsule-sponge device coupled with biomarkers and machine learning technologies.
In this prospective trial, we plan to recruit patients within three risk groups for ESCC: 1.
healthy controls; 2. high-risk individuals (previous head-and-neck cancer/ESCC); and 3.
patients with known early ESCC. Each patient will undergo a high-definition endoscopy and a
capsule-sponge examination. The biomarker assay, including p53-IHC and shallow whole genome
sequencing, will be tested within the capsule-sponge samples and compared with the final
endoscopic diagnosis. Machine learning algorithms will be applied to digitalized cytology to
detect atypical cells and regions of p53-IHC overexpression. Lastly, we will extract
microbial DNA from capsule-sponge samples to assess any taxonomic diversity within the three
risk groups for ESCC.
We hope to develop a novel, effective, and affordable diagnostic assay that, coupled with a
minimally-invasive capsule-sponge device, could be implemented in a clinical setting,
improving the early detection of ESCC and, eventually, patient outcomes.
