NCT05233007

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.

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: The Christie NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oesophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Minor endoscopic biopsy	As per standard of care

Timeline

• Start date: 2022-01-25
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2022-02-10
• Last updated: 2024-02-08

Locations

1 site across 1 country: United Kingdom