Molecular Characterisation of Serial Tumour Samples and Their Correlation With Circulating Biomarkers and Other Biospecimens Taken During the Clinical Course of Patients Receiving Treatment for Upper Gastrointestinal Carcinomas.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Determine levels of circulating biomarkers in upper GI cancer patients
研究概览
简要总结
This is a prospective translational research study in which tumour samples, blood samples and other biospecimens will be requested from patients with locally advanced or metastatic malignant oesophageal and gastric carcinoma. There are two parts to the study:
- Part A - evaluation of serial tumour biopsies
- Part B - evaluation of circulating biomarkers and other biospecimens
详细描述
This is a prospective, non-randomised, non-interventional, translational research study in which patients with locally advanced or metastatic oesophageal and gastric carcinoma will be asked to donate tissue, blood and other available biospecimens for translational and biomarker research. This is an exploratory biomarker study to generate preliminary data for future research projects incorporating identified aberrations.
The overall aims of the study are to employ serial tumour biopsies, blood borne biomarkers and other biospecimens to investigate mechanisms of resistance to systemic therapy and develop predictive biomarkers of this resistance in patients with locally advanced and metastatic malignant oesophageal and gastric carcinoma. Blood biomarkers will include enumeration and characterisation of circulating blood cell subtypes, as well as the evaluation of circulating cell-free proteins and nucleic acids. Other biospecimens include urine, stool and hair follicle samples that the patient is willing to donate for research purposes, and ascitic, pleural, pericardial or cerebral spinal fluid, available to collect as part of clinically indicated procedures (standard care) and surplus to routine clinical requirements. These other biospecimens would be stored at the Biobank.
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 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or more.
- •Patients must have given written informed consent.
- •Evidence of locally advanced or metastatic oesophageal and gastric carcinoma, i.e. stage III or IV disease.
- •Accessible tumour that can be safely biopsied using radiological or surgical techniques (if consenting to part A).
- •Full blood count and coagulation tests within acceptable parameters (if consenting to part A).
排除标准
- •Inability to provide informed consent.
- •History of significant bleeding disorder (patients on anticoagulation are eligible if the anticoagulation can be safely managed to allow fresh tumour biopsies and blood sampling).
- •History of HIV, Hepatitis B/C or other transmissible human disease.
- •Any conditions where research biopsies or blood sampling may increase risk of complications for the patient and/or investigator, including high risk groups such as intravenous drug users.
结局指标
主要结局
Determine levels of circulating biomarkers in upper GI cancer patients
时间窗: 20 years
To determine detectable levels of circulating biomarkers in patients with locally advanced and metastatic oesophageal and gastric carcinoma.
Correlating levels of biomarkers
时间窗: 20 years
To correlate circulating biomarker characteristics with serial tumour biopsies.
Predicting treatment resistance to anti-cancer therapy
时间窗: 20 years
To correlate sequencing/profiling data with clinical outcome data, including prognosis and response to systemic therapy.
次要结局
未报告次要终点
