Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523374
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-17
Brief Title:
A Study of Barretts Esophagus Patients to Investigate Quality of Life and Fear of Cancer and Optimize a Risk Model Based on Biomarkers and New Technologies to Better Predict the Development of Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early Esophageal Adenocarcinoma for Defining Cost Effective Surveillance Strategies and Prediction of Cancer Recurrence Prospective Pilot Cohort Study in Preparation of a Randomized Controlled Trial to Determine the Feasibility of a Risk Stratification Model for Barrett Esophagus Patients Based on Brush Cytology and to Test Novel High Throughput Methods for Assessing Biomarkers for Future Use
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Endeavor-1
Brief Summary:
This study serves in part to prepare for a future large cohort study The goal of the study is
1 The collection of various tissue samples blood biopsies and esophageal brushes and their analysis
2 To set up standardized methods for different genetic analyses DNA-FISH and so-called single cell sequencing on the esophageal tissue samples
3 Evaluating the quality of life of Barretts Esophagus patients and the degree of fear of getting cancer
Patients with a Barretts Esophagus can participate in the study if they are minimally 18 years old are capable of giving informed consent fully understanding what the study entails before giving consent to participate have Barrett Esophagus and are referred to one of the participating centers due to suspicion of high-grade dysplasia or early esophageal cancer for which the participant will be evaluated by endoscopic imaging and biopsy
Study procedures
An intake consultation will be planned wherein the eligibility criteria will be assessed and participant characteristics will be collected
A routine gastroscopy will be planned during which several minimally-invasive interventions will be performed drawing a blood sample brush cytology during the endoscopy a brush is used to obtain cells from the surface of the esophagus and obtaining biopsy samples small pieces of tissue Each participant will need to undergo all the interventions
1 The collection of various tissue samples blood biopsies and esophageal brushes and their analysis
2 To set up standardized methods for different genetic analyses DNA-FISH and so-called single cell sequencing on the esophageal tissue samples
3 Evaluating the quality of life of Barretts Esophagus patients and the degree of fear of getting cancer
Patients with a Barretts Esophagus can participate in the study if they are minimally 18 years old are capable of giving informed consent fully understanding what the study entails before giving consent to participate have Barrett Esophagus and are referred to one of the participating centers due to suspicion of high-grade dysplasia or early esophageal cancer for which the participant will be evaluated by endoscopic imaging and biopsy
Study procedures
An intake consultation will be planned wherein the eligibility criteria will be assessed and participant characteristics will be collected
A routine gastroscopy will be planned during which several minimally-invasive interventions will be performed drawing a blood sample brush cytology during the endoscopy a brush is used to obtain cells from the surface of the esophagus and obtaining biopsy samples small pieces of tissue Each participant will need to undergo all the interventions
Detailed Description:
More specifically you will have a standard endoscopy during which tissue samples will be taken from the esophagus to check for the severity of the disease This is part of standard care If you participate in the study additional samples will be taken from the esophagus and also from the stomach a total maximum of 10 samples of 1-2 mm As a result the endoscopic examination will take about 10-15 minutes longer than standard Furthermore in addition to the tissue samples cells of the esophageal mucosa will be sampled through 4 esophageal brushes and blood 4 tubes will also be collected
For this study you will be contacted a total of two times Once for a screening visit and once for the sample collection described above The screening and sample collection will take place during the already scheduled treatments and consultations Afterwards patient outcomes will be documented for the study until a maximum of 5 years after inclusion This documentation will take place during the routine follow up so does not require any additional visits for the patients
For this study you will be contacted a total of two times Once for a screening visit and once for the sample collection described above The screening and sample collection will take place during the already scheduled treatments and consultations Afterwards patient outcomes will be documented for the study until a maximum of 5 years after inclusion This documentation will take place during the routine follow up so does not require any additional visits for the patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None