Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06381583 |
| Other study ID # |
23228/EMERALD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2023 |
| Est. completion date |
April 24, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
City of Hope Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study aims to develop a highly sensitive, specific, and cost-effective blood assay for
the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced
machine learning and state-of-the-art biological analyses.
Description:
Esophageal adenocarcinoma (EAC) is a significant global health concern, ranking second in
lethality (after pancreatic cancer). Despite being potentially preventable, it remains a
leading cause of cancer-related deaths. Traditional screening methods have relied on an
endoscopy-first approach to screen for the precursor of EAC, which is Barrett's esophagus
(BE). After BE detection, BE is then regularly surveiled to monitor the development of
dysplasia, which can be treated to prevent malignant transformation. An endoscopy-first
approach is sensitive BE and, therefore, it lowers the risk of developing EAC but it also
faces challenges such as invasiveness, cost, and patient compliance.
Non-invasive tests are more appealing to patients than invasive tests and can increase
participation rates. Biomarker studies have shown promise, but existing tests lack
sensitivity for early-stage EAC and, most importantly, to its precursor lesion BE. This is
likely because they over-sampled analytes that are primarily expressed at the EAC end of the
spectrum, but not in BE yet during the BE to EAC sequence.
This study proposes developing an innovative liquid biopsy test tailored for EAC and BE to
address this. An ideal screening test should be minimally invasive, highly sensitive, and
cost-effective. This test would optimize patient compliance and resource allocation by
detecting both conditions from a single blood draw. More specifically, circulating microRNA
(miRNA) analysis shows promise: tests based on cell-free microRNA (cf-miRNA) have
demonstrated high sensitivity.
This study will develop a non-invasive blood test for BE and EAC in four phases:
1. In silico genome-wide profiling of tissue miRNA to select the best candidates for
biomarker panels.
2. Prioritization of the biomarkers that are differentially expressed across the entire
continuum of BE to EAC sequence, compared to the normal mucosa
3. Transition of these biomarkers to a liquid biopsy assay, confirming their detectability
in blood as well as their differential expression in cases compared to controls
4. Utilizing machine learning to identify the most promising candidates and train
algorithms for detecting EAC and BE, based on results from quantitative polymerase chain
reaction (qPCR) analysis.
5. Independently validating these signatures using diverse cohorts to ensure broad
applicability and compare the effectiveness of the blood assay to standard care through
retrospective and prospective studies.
This study aims to develop a highly sensitive, specific, and cost-effective liquid biopsy for
early detection of BE and EAC. Success could transform clinical practice by preventing EAC
through early detection of pre-malignant lesions. Innovations include incorporating
pre-malignant lesions into screening. This approach could potentially reduce EAC mortality
and incidence and pave the way for new clinical trials.
