Upper GI Serial Tumour Biopsies

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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.

Conditions
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Oesophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Procedure: Minor endoscopic biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>All eligible, consented participants, will be asked to give blood, tissue, and other biospecimens for research purposes | Procedure: Minor endoscopic biopsy<br>* As per standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine levels of circulating biomarkers in upper GI cancer patients | To determine detectable levels of circulating biomarkers in patients with locally advanced and metastatic oesophageal and gastric carcinoma. | 20 years | 
| Correlating levels of biomarkers | To correlate circulating biomarker characteristics with serial tumour biopsies. | 20 years | 
| Predicting treatment resistance to anti-cancer therapy | To correlate sequencing/profiling data with clinical outcome data, including prognosis and response to systemic therapy. | 20 years |