Upper GI Serial Tumour Biopsies

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.

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

Study Overview

• Status: Suspended
• Conditions: Gastric Cancer; Oesophageal Cancer
• Intervention / Treatment: Procedure: Minor endoscopic biopsy

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Sara Valpione, Dr; Phone Number: 0161 446 3472; Email: sara.valpione@nhs.net
• Study Contact Backup: Name: Kate Armitage; Phone Number: 0161 918 7887; Email: kate.armitage3@nhs.net

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M20 4BX
      • The Christie Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Upper GI cancer patients, as determined by practicing oncologist

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; All eligible, consented participants, will be asked to give blood, tissue, and other biospecimens for research purposes	Procedure: Minor endoscopic biopsy; As per standard of care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CFTSp209; 21/WM/0264 (Other Identifier: West Midlands - South Birmingham REC); 304901 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No