Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR 1 / BIORESOURCE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,005
- 试验地点
- 1
- 主要终点
- Levels of VOCs present in breath of subjects with PDAC and controls
研究概览
简要总结
Patients with early pancreatic cancer often have symptoms that could also be caused by many common benign conditions, or no symptoms at all. Jaundice, weight loss and pain are 'red flag' symptoms of pancreatic cancer that are linked to incurable disease. At the moment only patients with 'red flag' symptoms are urgently referred for diagnostic testing to find out if they have the cancer. As a result, late diagnosis is a common feature of pancreatic cancer. This leads to limited treatment options being available to patients by the time they are diagnosed, and ultimately results in poor survival rates.
There is a clear need to improve earlier detection of pancreatic cancer so that patients with pancreatic cancer can be identified earlier and faster, enabling them to start treatment more quickly.
The study team is developing a non-invasive breath test that detects small molecules called volatile organic compounds (VOCs) that may be altered by pancreatic cancers. For patients with non-specific symptoms, this test would help general practitioners (GPs) to identify those patients that may indeed have an underlying pancreatic cancer, who would benefit from referral for specialised pancreatic cancer tests.
详细描述
Bioresource study to identify pathways responsible for VOC production: A total of 192 patients will be recruited to provide samples to create a pancreatic biobank. This will be comprised of two groups, each containing 96 patients: (i) patients undergoing resection for pancreatic ductal adenocarcinoma (PDAC); (ii) control patients undergoing pancreatic resection for benign pancreatic disorders (e.g. intraductal papillary mucinous neoplasms, pancreatic mucinous cystic neoplasms, chronic pancreatitis). The following biosamples will be collected from each patient: breath, saliva, blood, urine, pancreatic tissue, duodenal aspirate. Collected samples will be stored in a biobank and will be utilised in a wide range of studies to investigate the mechanisms of VOC production in PDAC. The following analyses will be undertaken: volatolomics, metabonomics / lipidomics, metagenomics / microbiome analysis, transcriptomics, and culture experiments (to establish bacterial, immune and organoid cultures).
VAPOR 1 clinical study: Up to 813 patients will be recruited for the development of this non-invasive PDAC detection model. This will be comprised of three groups: (i) patients with PDAC; (ii) control patients with specified benign pancreatic disorders (new-onset diabetes mellitus, or chronic pancreatitis); (iii) control patients with non-specific gastrointestinal symptoms but a radiologically-normal pancreas. Participants will be required to fast for 6 hours prior to breath sampling. After rinsing their mouth with water, patients will be asked to provide breath samples by exhaling into single-use breath collection bags. Breath will be transferred using a precision pump into thermal desorption (TD) storage tubes. Breath samples will be analysed in accordance with existing quality-controlled processes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females
- •Adult patients ≥ 18 years old
- •VAPOR 1: patients with either a) Histologically confirmed PDAC*; b) New-onset diabetes mellitus or chronic pancreatitis; or c) Non-specific gastrointestinal symptoms, but a radiologically-normal pancreas
- •VAPOR Bioresource: patients undergoing pancreatic resection for a) Histologically confirmed PDAC*; or b) Benign pancreatic disorders e.g. intraductal papillary mucinous neoplasms, pancreatic mucinous cystic neoplasms, chronic pancreatitis
- •Note: *Patients undergoing surgery for suspected PDAC (without pre-operative histological confirmation) may be recruited assuming PDAC is confirmed within the resected specimen.
排除标准
- •Patients who have already received chemotherapy, radiotherapy or surgery for their PDAC
- •History of another cancer within the previous five years
- •Previous upper gastrointestinal surgery
- •Patients who are unable to provide a breath sample
- •Pregnant women
- •Patients unable to provide informed written consent
- •VAPOR 1: Patients with active infection, receiving immunosuppressive medications or antibiotics within the preceding eight weeks
- •VAPOR Bioresource: Patients receiving immunosuppressive medications within the preceding eight weeks
研究组 & 干预措施
VAPOR 1 - PDAC (pancreatic ductal adenocarcinoma)
304 treatment-naive patients with histologically-confirmed* PDAC will be recruited to provide breath samples.
*Patients that are due to undergo surgery for suspected PDAC (without pre-operative histological confirmation) may still be recruited despite the lack of pre-operative histological confirmation, assuming PDAC is subsequently confirmed within the resected specimen.
干预措施: Breath test (Diagnostic Test)
VAPOR 1 - Control patients with benign pancreatic disorders
257 patients with new-onset diabetes mellitus or chronic pancreatitis will be recruited to provide breath samples.
New-onset diabetes is defined as: HbA1c≥48mmol/mol (6.5%), diagnosed within the preceding 6 months.
干预措施: Breath test (Diagnostic Test)
VAPOR 1 - Control patients with non-specific GI symptoms and a normal pancreas
257 patients with non-specific gastrointestinal symptoms but a radiologically-normal pancreas will be recruited to provide breath samples.
Imaging to confirm a normal pancreas (CT / MRI / ultrasound) must have occurred within the preceding 12 months.
干预措施: Breath test (Diagnostic Test)
VAPOR Bioresource - PDAC (pancreatic ductal adenocarcinoma)
96 treatment-naive patients with histologically-confirmed* PDAC will be recruited to provide samples of breath, saliva, blood, urine, pancreatic tissue and duodenal aspirate.
*Patients that are due to undergo surgery for suspected PDAC (without pre-operative histological confirmation) may still be recruited despite the lack of pre-operative histological confirmation, assuming PDAC is subsequently confirmed within the resected specimen.
干预措施: Collection of matched samples of breath, biofluids and pancreatic tissue (Diagnostic Test)
VAPOR Bioresource - Control patients with benign pancreatic disorders
96 patients with benign pancreatic disorders (such as intraductal papillary mucinous neoplasms, pancreatic mucinous cystic neoplasms, chronic pancreatitis) will be recruited to provide samples of breath, saliva, blood, urine, pancreatic tissue and duodenal aspirate.
干预措施: Collection of matched samples of breath, biofluids and pancreatic tissue (Diagnostic Test)
结局指标
主要结局
Levels of VOCs present in breath of subjects with PDAC and controls
时间窗: 24 months
Gas Chromatography-Mass Spectrometry (GC-MS) will be used to identify the levels (measured in parts per billion, ppb) of certain cancer-associated VOCs in breath
次要结局
- Characterisation of bacterial species in saliva samples, pancreatic tissue samples and duodenal aspirate samples of subjects with PDAC compared to controls(24 months)
- Levels of volatile metabolites present in headspace of the urine of subjects with PDAC and controls(24 months)
- Levels of VOCs produced by the bacteria isolated from saliva samples, pancreatic tissue samples and duodenal aspirate samples of subjects with PDAC(24 months)