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Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06289374
Acronym
LABS
Enrollment
100
Registered
2024-03-01
Start date
2025-02-28
Completion date
2029-06-30
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Adenocarcinoma, Oesophageal Adenocarcinoma

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.

Interventions

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

Sponsors

Cancer Research UK
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Salivary microbial biomarkers to predict treatment response and long-term prognosis48 monthsChanges in the presence and/or abundance of bacteria over a 2 year period, measured primarily within saliva.

Secondary

MeasureTime frameDescription
Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment48 monthsChanges in the VOC profile using gas chromatography mass spectrometry.
Quality of life measure up to 2 years following cancer surgery using validated questionnaires48 monthsAssessment in the longitudinal changes of quality of life measures using validated questionnaires.

Countries

United Kingdom

Contacts

Primary ContactBhamini Vadhwana, MRCS, PhD
b.vadhwana@imperial.ac.uk+44 (0)20 7594 3396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026