Clinical trial NCT05233007: Upper GI Serial Tumour Biopsies
Official title: 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.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Oesophageal Cancer
Gastric Cancer
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Upper GI cancer patients, as determined by practicing oncologist

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine levels of circulating biomarkers in upper GI cancer patients
timeFrame: 20 years
measure: Correlating levels of biomarkers
timeFrame: 20 years
measure: Predicting treatment resistance to anti-cancer therapy
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie Hospital NHS Foundation Trust
state: Greater Manchester
Study officials:
References: