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NCT Number: NCT06289374

Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery

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.

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Key information

Conditions

Oesophageal Adenocarcinoma Adenocarcinoma Of Esophagus Gastric Adenocarcinoma

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location status: Recruiting

Location contact

Bhamini Vadhwana

CONTACT

Professor George Hanna, PhD FRCS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biosample Collection

Other

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

Primary outcomes

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

    Time frame: 48 months

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

Secondary outcomes

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

    Time frame: 48 months

    Changes in the VOC profile using gas chromatography mass spectrometry.

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

    Time frame: 48 months

    Assessment in the longitudinal changes of quality of life measures using validated questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Bhamini Vadhwana, MRCS, PhD

CONTACT

[email protected]

+44 (0)20 7594 3396

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Cancer Research UK

Registry information

Official study title

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

Acronym: LABS

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 1, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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