A Prospective, Interventional Clinical Study to Develop a Cancer Detection Model for Oesophageal Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,350
- 试验地点
- 9
- 主要终点
- A clinical prediction model to detect oesophageal cancer based on difference in VOCs between oesophageal cancer and non-cancer participants.
研究概览
简要总结
This study is a multicenter, randomized, observational study to develop a clinical prediction model (CPM) to detect oesophageal cancer based on the volatile organic compounds (VOCs) observed in exhaled breath and to examine its diagnostic accuracy. This study has 2 phases - Screening period, breath sample collection phase. At the randomization visit, participants who meet all of the eligibility criteria will be randomized to receive oral stimulant drink (OSD) after collection of baseline breath sample collection. Post drinking OSD, at 15 min another breath sample will be collected. The augmented response of specific VOCs in the exhaled breath for detecting oesophageal cancer will also be observed along with assessing the safety and tolerability related to the consumption of the oral stimulant drink (OSD) in the study participants.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Cohort 1 Participant will be eligible for inclusion in this study only if all of the following criteria apply:
- •Male or non-pregnant female participant aged between 18 to 80 years (both inclusive)
- •Participant with biopsy proven oesophageal squamous cell cancer or oesophageal/gastrooesophageal junction adenocarcinoma who are awaiting treatment.
- •Participant agrees to comply with the study requirements and provide written informed consent to participate in the study.
- •Participant with benign conditions or normal gastrointestinal tract with upper gastrointestinal symptoms determined by endoscopy within 1 year.
- •Participant with suspected oesophageal squamous cell cancer or oesophageal/gastrooesophageal junction adenocarcinoma who is awaiting biopsy result to confirm presence of squamous cell cancer or adenocarcinoma.
排除标准
- •Cohort 1 Participant will not be eligible for inclusion in this study if any of the following criteria apply:
- •Participant with previous oesophageal and gastric resection.
- •Participant who has received neoadjuvant chemotherapy for oesophageal or gastric cancer.
- •Participant with a history of another cancer within three years.
- •Participant with an active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks.
- •Participant with allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, maltodextrin (corn, potato), xanthan gum, potassium chloride, tyrosine, phenylalanine, and glutamic acid.
- •Female participant who is pregnant, breast feeding, or planning a pregnancy.
- •Female of childbearing potential who does not agree to utilize an adequate form of contraception during the study duration.
- •Participant has previously been enrolled in this study.
- •Any other condition that, in the investigator’s judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •Participant with an oesophageal squamous cell carcinoma.
- •Participant with any form of oesophageal dysplasia.
- •Participant with previously diagnosed with Barrett’s oesophagus.
结局指标
主要结局
A clinical prediction model to detect oesophageal cancer based on difference in VOCs between oesophageal cancer and non-cancer participants.
时间窗: 24 hr
次要结局
- a. Incidence of adverse events (AEs) and serious adverse events (SAEs). Incidence of adverse events (AEs) and serious adverse events (SAEs) will be summarized by count (n) and percentage in the two groups separately and combined.(b. The variation in VOCs following the consumption of OSD. Variation in VOCs will be analyzed by descriptive statistics. Above analysis will be performed on the safety population. Detailed statistical methodology will be prepared in the Statistical Analysis plan (SAP).)
研究者
Dr Dharmesh Domadia
Cliantha Research Limited