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Recruiting NCT06289374

Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery

Observational Oesophageal Adenocarcinoma Gastric Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biosample collection.
Who it may be relevant to
Registry conditions: Oesophageal Adenocarcinoma, Gastric Adenocarcinoma. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The LABS Study: Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery (BIORESOURCE 2: Longitudinal)

Overview

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.

Interventions

  • Other Biosample collection
    Collection of saliva, urine, blood, breath and quality of life questionnaires.

Primary outcome measures

  • Salivary microbial biomarkers to predict treatment response and long-term prognosis [Time frame: 48 months]
Secondary outcome measures (2)
  • Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment [Time frame: 48 months]
  • Quality of life measure up to 2 years following cancer surgery using validated questionnaires [Time frame: 48 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United Kingdom · 1 center
  • Imperial College Healthcare NHS Trust — London

Identifiers

NCT: NCT06289374 · 23HH8340

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗