Measurement of Oxidation Reduction Potential in the Colon Using an Ingestible Sensor in Patietns With Ulcerative Colitis (UC) and Colorectal Cancer (CRC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Disease activity (FC)
研究概览
简要总结
The goal of this observational pilot study with invasive measurements is to explore whether an ingestible sensor pill can be of use in diagnosis or monitoring of disease in patients with ulcerative colitis or colorectal cancer. The main questions it aims to answer are:
- which changes in bowel environment can the sensor pill measure in ulcerative colitis and colorectal cancer before and after treatment?
- how practical, effective and user-friendly is the sensor pill for measuring bowel environment in patients with bowel disease?
Participants will:
- take one sensor pill before treatment and take one sensor pill three months after (start of) treatment;
- monitor sensor pill bowel exit using a small wearable device;
- answer a questionnaire on experience with the sensor pill;
- receive an extra bowel ultrasound (non-endoscopic) three months after start of treatment (only for participants with ulcerative colitis).
详细描述
Rationale: The gold standard diagnostic tool for inflammatory bowel disease (IBD) and colorectal carcinoma (CRC) is endoscopy, which can be burdensome for patients. The future of IBD care demands novel, minimally invasive biomarkers for personalized care and CRC screening programs could greatly benefit from new minimally invasive diagnostic tools. Oxidative stress plays a significant role in the progression of gut inflammation and colorectal cancer. Using an ingestible sensor, we aim to measure oxidation-reduction potential (ORP) directly in the gut. We hypothesize that it is feasible to measure intestinal ORP with an ingestible sensor and expect that ORP levels are elevated in patients with active ulcerative colitis (UC) and CRC before treatment, compared to after treatment.
Objective: Measurement of intestinal oxidation-reduction potential using a smart sensing ingestible and its relation to active UC and CRC.
Study design: Observational, exploratory study with invasive measurements.
Study population: 5 patients ≥ 18 years of age with UC and 5 patients ≥ 18 years of age with CRC
Main study parameters/endpoints: The main study parameter is colonic ORP profiles measured with the ingestible sensor ingestible compared before and after treatment for UC and CRC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •(For all participants:)
- •Age ≥ 18 years old;
- •willing and able to provide informed consent;
- •defaecation pattern: generally at least one defaecation per 48 hours.
- •(For the UC group:)
- •Diagnosis of UC confirmed by clinical, endoscopic, and/or histological evidence prior to screening as per standard criteria;
- •moderately to severely active UC determined by intestinal ultrasound (bowel wall thickness (BWT) > 3 mm), starting treatment or requiring change in treatment due to non-response to their existing treatment;
- •starting or optimizing treatment for colitis (including aminosalicylates, oral corticosteroids, thiopurines, biologics and small molecules).
- •(For the CRC group:)
- •Diagnosis of non-obstructing non-locally advanced colorectal adenocarcinoma;
- •ready/planned for surgery of CRC.
排除标准
- •(For all participants:)
- •Body mass index (BMI) > 30 kg/m^2;
- •known obstruction, stricture or stenosis in the gastrointestinal tract not attributable to current inflammation or tumour, potentially blocking ingestible passage. Determined as per discretion of gastroenterologist/oncologist using standard procedural clinical diagnostic or imaging techniques;
- •history of complex bowel resection or recent intra-abdominal surgery (< 3 months);
- •known abdominal adhesions;
- •swallowing disorders, including achalasia or oropharyngeal dysfunction;
- •ongoing infections;
- •known to be pregnant, lactating or actively trying to get pregnant (self-reported);
- •short bowel syndrome or ostomy;
- •only parenteral diet;
- •pacemaker or other implantable electronic devices;
- •planned magnetic resonance imaging (MRI) procedure during the ingestible meaurement period;
- •unwilling to undergo an X-ray examination (in the case ingestible exit cannot be confirmed);
- •participation in other medical interventional/Wet medisch-wetenschappelijk onderzoek (WMO)-compliant reearch;
- •participant is working (as medical personnel) in a professional healthcare facility (intensive care, emergency room, surgery rooms, clinics, patient rooms), military area (e.g. submarine, near radar installation), or heavy industrial area (e.g. power plants, automotive, mining, refineries) during the duration of the clinical investigation.
- •(For the CRC group:)
- •Diagnosis or strong suspicion of IBD;
- •planned treatment with adjuvant chemotherapy or radiotherapy.
- •(For the UC population:)
- •Diagnosis or strong suspicion of colorectal adenocarcinoma;
- •use of rectal foam/enema during the measurement period.
结局指标
主要结局
Disease activity (FC)
时间窗: Baseline and at 3 months after treatment start.
UC disease activity as determined by the faecal calprotectin (in microgram/gram)
Tumor stage
时间窗: Directly after surgical resection
TNM tumor stage as recorded in pathology report.
Tumor resection margin status
时间窗: Directly after surgical resection
Residual tumor at the primary site after surgical resection as classified in pathology report.
Intestinal ORP measurements
时间窗: Baseline and at 3 months after start of treatment.
ORP profile in the colon using the GISMO GEN1 System in patients with UC or CRC.
Disease activity (SCCAI)
时间窗: Baseline and 3 months after start of treatment.
UC disease activity as determined by the Simple Clinical Colitis Activity Index
Tumor size
时间窗: Directly after surgical resection
Tumor size as recorded in surgery report.
Tumor differentiation grade
时间窗: Directly after surgical resection
Tumor differentiation grade as recorded in pathology report.
次要结局
- Intestinal pH(From enrollment to 3 months after start of treatment.)
- Area of inflammation(Directly after intestinal ultrasound.)
- Tumour location(Directly post-surgery.)
- Data coverage(Baseline and at 3 months after start of treatment)
- Participant experience(Up to 1 month after exit of the post-treatment ingestible sensor capsule measurement period.)
- Ingestible transit time.(Baseline and at 3 months after start of treatment.)