Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery

Recruiting

• Conditions: Gastric Adenocarcinoma; Oesophageal Adenocarcinoma
• Interventions: Other: Biosample collection

• Registration Number: NCT06289374
• Lead Sponsor: Imperial College London

Brief Summary

Oesophagogastric cancer (cancer of the gullet and stomach) is the fifth most common cancer in England and Wales with 16,000 new cases diagnosed every year. Survival rates are poor with only 15% surviving beyond 5 years. There is also increasing research to understand the cancer biology and factors allowing cancers to progress. It is likely there is a relationship between the cancer-specific microbiome, cells related to inflammation, which promotes cancer progression. The BIORESOURCE 1 study has established a comprehensive resource of matched samples from patients with oesophageal and gastric cancer. This longitudinal study aims to obtain further matched biosamples in the follow-up period after cancer surgery to find biomarkers that may predict treatment response, recurrence and/or long term prognosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-01
• Status Verified: 2025-02
• Study Start: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2028-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged 18-90 years at the time of initial recruitment
• Gastric/oesophageal adenocarcinoma cohort (biopsy proven adenocarcinoma) recruited into BIORESOURCE 1

Exclusion Criteria

• Oesophageal squamous cell carcinoma
• Previous oesophageal and gastric resection
• History of another cancer within five years. If a new other cancer type is diagnosed within the sampling time frame, no further samples will be taken.
• Participants with co-morbidities preventing breath collection
• Unable or unwilling to provide informed written consent
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The LABS study (Bioresource 2: Longitudinal)	Biosample collection	200 patients following oesophagogastric cancer resection recruited into BIORESOURCE 1. Following surgery at 3 months, 6 months, 1 year and 2 years: saliva, urine, blood, breath and quality of life questionnaires will be collected.

Primary Outcome Measures

Name	Time	Method
Salivary microbial biomarkers to predict treatment response and long-term prognosis	48 months	Changes in the presence and/or abundance of bacteria over a 2 year period, measured primarily within saliva.

Secondary Outcome Measures

Name	Time	Method
Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment	48 months	Changes in the VOC profile using gas chromatography mass spectrometry.
Quality of life measure up to 2 years following cancer surgery using validated questionnaires	48 months	Assessment in the longitudinal changes of quality of life measures using validated questionnaires.

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom