Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery

NCT06289374 | Recruiting

• 1 other identifier: 23HH8340
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Oesophageal Adenocarcinoma; Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Salivary microbial biomarkers to predict treatment response and long-term prognosis

  Changes in the presence and/or abundance of bacteria over a 2 year period, measured primarily within saliva.

  48 months

Secondary Outcomes (2)

• Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment

  48 months

• Quality of life measure up to 2 years following cancer surgery using validated questionnaires

  48 months

Study Arms (1)

The LABS study (Bioresource 2: Longitudinal)

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.

Other: Biosample collection

Interventions

Biosample collection OTHER

Collection of saliva, urine, blood, breath and quality of life questionnaires.

The LABS study (Bioresource 2: Longitudinal)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients seen in a hospital (secondary or tertiary level care) setting

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Cancer Research UK: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Central Study Contacts

Bhamini Vadhwana, MRCS, PhD

CONTACT

+44 (0)20 7594 3396; b.vadhwana@imperial.ac.uk

Study Design

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

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 1, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)