Oesophageal AdenocarcinomaLABSNCT06289374
Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery
An observational study of Oesophageal Adenocarcinoma and Gastric Adenocarcinoma, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Oesophageal Adenocarcinoma, Gastric Adenocarcinoma
- What is being tested?
- Biosample collection
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2025to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen in a hospital (secondary or tertiary level care) setting
Who may be able to join
- Aged 18-90 years at the time of initial recruitment
- Gastric/oesophageal adenocarcinoma cohort (biopsy proven adenocarcinoma) recruited into BIORESOURCE 1
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London
Bhamini Vadhwana
Professor George Hanna, PhD FRCS
About this study
Official title: 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.
- Conditions
- Oesophageal Adenocarcinoma, Gastric Adenocarcinoma
- Being tested
- Biosample collection
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosample collectionOther
Collection of saliva, urine, blood, breath and quality of life questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biosample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 months
Secondary outcomes (2)
Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment
Changes in the VOC profile using gas chromatography mass spectrometry.
Measured: 48 months
Quality of life measure up to 2 years following cancer surgery using validated questionnaires
Assessment in the longitudinal changes of quality of life measures using validated questionnaires.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study startFeb 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289374
- Sponsor's protocol ID
- 23HH8340
- Acronym
- LABS
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LABS Study: Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery (BIORESOURCE 2: Longitudinal)
- ClinicalTrials.gov ID
- NCT06289374
- Acronym / sponsor ID
- LABS / 23HH8340
- Conditions
- Oesophageal Adenocarcinoma, Gastric Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The LABS study (Bioresource 2: Longitudinal) | – | Other: Biosample collection200 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in a hospital (secondary or tertiary level care) setting
Key inclusion criteria (2 listed)
- Aged 18-90 years at the time of initial recruitment
- Gastric/oesophageal adenocarcinoma cohort (biopsy proven adenocarcinoma) recruited into BIORESOURCE 1
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biosample collectionCollection of saliva, urine, blood, breath and quality of life questionnaires. | Other | The LABS study (Bioresource 2: Longitudinal) |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophageal Adenocarcinoma and Gastric Adenocarcinoma, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bhamini Vadhwana, MRCS, PhD (+44 (0)20 7594 3396, b.vadhwana@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary microbial biomarkers to predict treatment response and long-term prognosis (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.