A Study of Barrett's 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

Официальное название

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

Обзор

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 Barrett's Esophagus patients and the degree of fear of getting cancer. Patients with a Barrett's 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 twice 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. * Patients will have to complete questionnaires at three time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).

Подробное описание

More specifically, you will have a standard endoscopy twice 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 three times. Once for a screening visit and twice 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. Additionally you will be asked to complete two short questionnaires on your mobile phone at three time points during the study.

Вмешательства

• Процедура Endoscopic brush cytology
  A total of four brush samples will be taken during the endoscopy. Other minimally invasive interventions during this study are standard of care.

Первичные конечные точки

• Success rate of brush, biopsy and blood samples obtained from different sites for analysis by HTP technologies [Срок оценки: 6-12 months]
• Success rate of DNA-FISH analyses on the brush cytology samples [Срок оценки: 6-12 months]

Вторичные конечные точки (5)

• Accuracy of a DNA-FISH based risk model [Срок оценки: 6-24 months]
• Correlation of a DNA-FISH based risk model [Срок оценки: 6-24 months]
• Standard operating procedures for specimen collection [Срок оценки: 6-24 months]
• Standard operating procedures for logistical procedures [Срок оценки: 6-24 months]
• Successful participation and answering of questionnaires [Срок оценки: 6-24 months]

Критерии участия

Критерии включения

• Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of early esophageal Barrett cancer
• Capable of receiving informed consent and of giving permission
• Age 18 and upward

Критерии исключения

• Patients with current known malignancy of the gastrointestinal tract other than the esophageal lesion
• Patients with severe co-morbidity that prohibits endoscopic therapy under sedation or conscious sedation (such as severe cardiac or pulmonary disease)
• Esophageal varices
• Uncontrollable coagulation disorders
• Undergoing chemotherapy or immunotherapy or received chemotherapy < 6 weeks prior to endoscopy
• Undergoing radiotherapy within the esophageal region or received chemotherapy < 6 months prior to endoscopy
• WHO score > 3

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Бельгия · 4 центра

• University Hospital Antwerp — Edegem
• Sint-Augustinus Hospital (ZAS) — Wilrijk
• UZ Gent — Ghent
• AZ Delta — Roeselare

Дания · 1 центр

• Rigshospitalet — Copenhagen

Франция · 1 центр

• CHU LILLE - Centre Hospitalier Universitaire de Lille — Lille

Ирландия · 1 центр

• St James's Hospital — Dublin

Италия · 1 центр

• IRCCS Ospedale San Raffaele — Milan

Швеция · 1 центр

• Karolinska University Hospital — Solna

Идентификаторы

NCT: NCT06523374 · EDGE3788 · 101136935

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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