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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 266
- 试验地点
- 10
- 主要终点
- Disease recurrence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
In this trial, there will be two arms:
- Control group = dubbel blind (investigator and patient are blinded for the results of the risk profile).
- Intervention group = open label = patients will be informed by the investigator on their risk profile.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
Participants in the intervention arm will be informed by the investigator on their genetic risk profile.
干预措施: Risk profile disclosure (Other)
Control
Participants in the control arm will not be informed by the investigator on their genetic risk profile. Both the participant and the investigator are not aware of the genetic risk profile.
结局指标
主要结局
Disease recurrence
时间窗: From endoscopic resection up to three years after endoscopic eradication therapy
Extraluminal recurrence (regional, distal) of cancer, endoluminal recurrence (metachronous, local) of cancer, endoluminal recurrence of dysplasia
Cancer Worry Scale
时间窗: After cessation of endoscopic eradication therapy (EET), assessed up to 5 years after inclusion
Cancer Worry Scale (total score, 8-item version) after cessation of endoscopic eradication therapy (EET)
Economic costs
时间窗: From end of endoscopic eradication therapy until three years after endocsopic eradication therapy
Economic costs in euro for surveillance programme (including endoscopic procedures, biomarker analysis and materials)
次要结局
- Clonal diversity score(Between the baseline endoscopy (visit 1) and first endoscopy after endoscopic resection (visit 2))
- Disease stage(From patient inclusion until three years after endoscopic eradication therapy)
- Missing data ePRO(From start of inclusion until three years after endoscopic eradication)
- Caregiver's satisfaction(From start inclusion until three years after endoscopic eradication)
- Drop-out(From start inclusion until three years after endoscopic eradication)
- Follow-up years(From end of endoscopic eradication therapy until year three after endoscopic eradication)
- Cancer worry scale longitudinal(From start of inclusion until year three after endscopic eradication therapy)
- EQ-5D-5L(From start of inclusion until three years after endoscopic eradication)
- Quality adjusted life years (QALY)(From start of inclusion until three years after endoscopic eradication)
- Endoscopy timepoint(From end of endoscopic resection until three years after endoscopic eradication therapy)
- Histopathological disease stage(From end of endoscopic resection until three years after endoscopic eradication)
- Treatment stage recurrence(From endoscopic resection until three years after endocopic eradication)
- Mortality events(From endoscopic resection until three years after endoscopic eradication)
- Number of ablation sessions(From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion)
- Number of CE-IM patients(From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion)
- Number of RFA therapy-resistant patients(From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion)
- Local recurrence(From endoscopic resection until three years after endoscopic eradication)