Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418516
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
Early Detection of Esophageal Squamous Cancer With the Capsule Sponge Device
Sponsor:
Centre of Postgraduate Medical Education
Organization:
Centre of Postgraduate Medical Education
Study Overview
Official Title:
Early Detection of Esophageal Squamous Cell Carcinoma With the Capsule Sponge Device Coupled With Molecular Biomarkers and Machine Learning
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANGELA
Brief 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
Detailed Description:
Esophageal squamous cell carcinoma ESCC is the most common type of esophageal cancer worldwide accounting for nearly 90 of the 456000 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 38 and 149 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 Barretts 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 cancerESCC 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
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 Barretts 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 cancerESCC 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None