A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurrence and the Effect of Risk Profile Disclosure on Patient Quality of Life and Fear of Cancer

Официальное название

A Randomized Controlled Trial Using Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early ESOPHAGEAL ADENOCARCINOMA for Assessing Effects on Quality of Life, Cancer Worry and Defining Cost-Effective Surveillance Strategies

Обзор

The goal of the study is: * The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis. * To test a risk model based on genetic analyses (DNA-FISH and so-called single cell sequencing) on esophageal tissue samples. * 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 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 several time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale). This study is a randomized trial, meaning the study participants will be divided into two groups by the computer. One group will be informed of their risk profile, established based on the genetic analyses. The other group will not be informed of their risk profile. All patients will be followed-up in a more intensive surveillance schedule compared to the standard of care, for study purposes.

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 (up to 4 tubes) will also be collected.

For this study, you will be contacted a total of four times. Once for a screening visit and twice for the sample collection described above. One last visite will be planned to discuss the risk profile, depending on the randomization group. After your initial treatment, you will be enrolled in a standard-of-care treatment schedule depending on your specific circumstances. This standard-of-care treatment schedule will coincide with the intensified surveillance schedule to detect recurrence earlier.

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 several time points during the study.

Вмешательства

• Другое Risk profile disclosure
  Participants in the intervention arm will be informed by the investigator on their genetic risk profile.

Первичные конечные точки

• Disease recurrence [Срок оценки: From endoscopic resection up to three years after endoscopic eradication therapy]
• Cancer Worry Scale [Срок оценки: After cessation of endoscopic eradication therapy (EET), assessed up to 5 years after inclusion]
• Economic costs [Срок оценки: From end of endoscopic eradication therapy until three years after endocsopic eradication therapy]

Вторичные конечные точки (12)

• Clonal diversity score [Срок оценки: Between the baseline endoscopy (visit 1) and first endoscopy after endoscopic resection (visit 2)]
• Disease stage [Срок оценки: From patient inclusion until three years after endoscopic eradication therapy]
• Missing data ePRO [Срок оценки: From start of inclusion until three years after endoscopic eradication]
• Caregiver's satisfaction [Срок оценки: From start inclusion until three years after endoscopic eradication]
• Drop-out [Срок оценки: From start inclusion until three years after endoscopic eradication]
• Follow-up years [Срок оценки: From end of endoscopic eradication therapy until year three after endoscopic eradication]
• Cancer worry scale longitudinal [Срок оценки: From start of inclusion until year three after endscopic eradication therapy]
• EQ-5D-5L [Срок оценки: From start of inclusion until three years after endoscopic eradication]
• Quality adjusted life years (QALY) [Срок оценки: From start of inclusion until three years after endoscopic eradication]
• Endoscopy timepoint [Срок оценки: From end of endoscopic resection until three years after endoscopic eradication therapy]
• Histopathological disease stage [Срок оценки: From end of endoscopic resection until three years after endoscopic eradication]
• Treatment stage recurrence [Срок оценки: From endoscopic resection until three years after endocopic eradication]

Критерии участия

Критерии включения

• Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of T1 oesophageal 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 refusing randomization and corresponding follow-up intervals based on biomarker profile
• 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/planned chemotherapy or immunotherapy or received chemotherapy < 6 months prior to endoscopy
• Undergoing/planned radiotherapy within the esophageal region or received radiotherapy < 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Диагностика

Центры проведения

Бельгия · 4 центра

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

Дания · 1 центр

• Rigshospitalet — Copenhagen

Франция · 1 центр

• CHU LILLE - Centre Hospitalier Universitaire de Lille — Lille

Германия · 1 центр

• University Hospital Leipzig — Leipzig

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: NCT07455422 · CTMS33247 · 101136935

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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