SuspendedNot Applicable

Upper GI Serial Tumour Biopsies

Stopped: To explore alternative funding streams

United Kingdom300 participantsStarted 2022-01-25

Plain-language 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

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Determine levels of circulating biomarkers in upper GI cancer patients

Timeframe: 20 years

Correlating levels of biomarkers

Timeframe: 20 years

Predicting treatment resistance to anti-cancer therapy

Timeframe: 20 years

Trial details

NCT IDNCT05233007

SponsorThe Christie NHS Foundation Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-10

View on ClinicalTrials.gov More Oesophageal Cancer trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.