Upper GI Serial Tumour Biopsies

NCT05233007 | Suspended

• 3 other identifiers: CFTSp20921/WM/0264304901
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Oesophageal Cancer; Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

All participants

All eligible, consented participants, will be asked to give blood, tissue, and other biospecimens for research purposes

Procedure: Minor endoscopic biopsy

Interventions

Minor endoscopic biopsy PROCEDURE

As per standard of care

All participants

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Upper GI cancer patients, as determined by practicing oncologist

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie Hospital NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumour biopsies, whole blood and blood products

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 10, 2022
• Study Start: January 25, 2022
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

GB (1)