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
概览
- 阶段
- 不适用
- 干预措施
- Endoscopic brush cytology
- 疾病 / 适应症
- Barrett's Esophagus
- 发起方
- University Hospital, Antwerp
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Success rate of DNA-FISH analyses on the brush cytology samples
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
This study serves, in part, to prepare for a future large cohort study. The goal of the study is:
- The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis.
- To set up standardized methods for different genetic analyses (DNA-FISH and so-called single cell sequencing) on the 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 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).
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 (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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Endoscopic brush cytology
Each participant will receive all interventions. A routine endoscopy will be planned during which several minimally invasive interventions will be performed: drawing a blood sample (standard of care), brush cytology (not standard of care) and biopsies (standard of care) during the endoscopy.
干预措施: Endoscopic brush cytology
结局指标
主要结局
Success rate of DNA-FISH analyses on the brush cytology samples
时间窗: 6-12 months
Our second primary outcome measure for this pilot study is successful DNA-FISH analysis (successful = at least 50 cells that can be analyzed in at least 80% of participants) on the brush cytology samples for defining the final risk model that will be applied in the randomized controlled trial following the pilot study.
Success rate of brush, biopsy and blood samples obtained from different sites for analysis by HTP technologies
时间窗: 6-12 months
We will determine the success rate of obtaining material from different sites for analysis by high throughput technologies (Next Generation Sequencing) of the brush, biopsy or blood samples. A rate of analysable cells of at least 80% of the specimens will be regarded as successful.
次要结局
- Correlation of a DNA-FISH based risk model(6-24 months)
- Successful participation and answering of questionnaires(6-24 months)
- Accuracy of a DNA-FISH based risk model(6-24 months)
- Standard operating procedures for specimen collection(6-24 months)
- Standard operating procedures for logistical procedures(6-24 months)