University hospital Ghent
Ghent, Oost-Vlaanderen, 9000, Belgium
Location status: Recruiting
Location contact
Annouck Philippron, MD
CONTACT
Piet Pattyn, MD, PhD
CONTACT
NCT Number: NCT05688176
This study is designed to perform a explorative search of the transcriptome to detect new circulating diagnostic sensitive and specific biomarkers in patients with Barrett's esophagus or esophageal adenocarcinoma.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ghent, Oost-Vlaanderen, 9000, Belgium
Location status: Recruiting
Annouck Philippron, MD
CONTACT
Piet Pattyn, MD, PhD
CONTACT
By developing new tools for risk-assessing of Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) in a population at risk, the investigators expect that diagnosis can be done in an earlier stage resulting in an improved 5-year survival. A proof-of-concept RNA profiling study will be done in 20 BE and EAC patients where 2 biomaterials (tissue and plasma) and 2 RNA biotopes (micro RNA and messenger RNA) will be compared. Previously validated methodology on small RNA and messenger RNA capture sequencing on both tissue and plasma will be used to obtain high-quality data. Differential expression analysis will be done on tissue and plasma sample data. Additional in-depth data-mining will be done, amongst other focusing on structural information encoded in the transcriptome and building a multifeature classifier. These findings will be validated in a large validation cohort, followed by development of a clinical-grade quantitative Polymerase Chain Reaction (qPCR) test, ready for testing in an independent cohort.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 years
Identification of micro RNAs in plasma and tissue of patients with (non-)dysplastic Barrett's esophagus and EAC that are differentially abundant, compared to healthy plasma (healthy volunteers) or healthy tissue (patient-matched healthy esophagus biopsies).
Time frame: 4 years
Identification of messenger RNAs in plasma and tissue of patients with (non-)dysplastic Barrett's esophagus and EAC that are differentially abundant, compared to healthy plasma (healthy volunteers) or healthy tissue (patient-matched healthy esophagus biopsies).
Time frame: 2 years
Identification of a set of messenger RNAs that change during treatment (using longitudinally collected plasma samples) and that separate responders from non-responders to neo-adjuvant radiochemotherapy.
Time frame: 1 year
After development and validation on an independent cohort, this test should be evaluated in a second external cohort
Contact information is provided by the study sponsor or research team.
Annouck Philippron, MD
CONTACT
Piet Pattyn, MD, PhD
CONTACT
University Hospital, Ghent
Other
Liquid Biopsies in Esophageal Adenocarcinoma: Barrett's Esophagus and Esophageal Adenocarcinoma, Searching for Reliable Diagnostic RNA Plasma-based Biomarkers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06445972
Digestive System Diseases, Digestive System Neoplasms
Tucson, Arizona, United States
View Trial DetailsNCT07114601
Breast Diseases, Breast Neoplasms
Duarte, California, United States
View Trial DetailsNCT06077981
Digestive System Diseases, Digestive System Neoplasms
São Paulo, Brazil
View Trial DetailsNCT06070376
Deglutition Disorders, Digestive System Diseases
São Paulo, Brazil
View Trial Details