Status:

SUSPENDED

Upper GI Serial Tumour Biopsies

Lead Sponsor:

The Christie NHS Foundation Trust

Conditions:

Oesophageal Cancer

Gastric Cancer

Eligibility:

All Genders

18-100 years

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 oesophage...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 25 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2028

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT05233007

Start Date

January 25 2022

End Date

October 1 2028

Last Update

February 8 2024

Active Locations (1)

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1

The Christie Hospital NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom, M20 4BX