Upper GI Serial Tumour Biopsies

Suspended

• Conditions: Oesophageal Cancer; Gastric Cancer

• Registration Number: NCT05233007
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-01-25
• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Age of 18 years or more.
2. Patients must have given written informed consent.
3. Evidence of locally advanced or metastatic oesophageal and gastric carcinoma, i.e. stage III or IV disease.
4. Accessible tumour that can be safely biopsied using radiological or surgical techniques (if consenting to part A).
5. Full blood count and coagulation tests within acceptable parameters (if consenting to part A).

Exclusion Criteria

1. Inability to provide informed consent.
2. 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).
3. History of HIV, Hepatitis B/C or other transmissible human disease.
4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Christie Hospital NHS Foundation Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom