Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery (LABS)

March 4, 2024 updated by: Imperial College London

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
          • Bhamini Vadhwana
        • Principal Investigator:
          • Professor George Hanna, PhD FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Collection of saliva, urine, blood, breath and quality of life questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 months
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.
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Cancer Research UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23HH8340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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