Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery

NCT ID: NCT06289374

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-28

Study Completion Date

2029-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oesophageal Adenocarcinoma Gastric Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Biosample collection

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biosample collection

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cancer Research UK

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bhamini Vadhwana, MRCS, PhD

Role: CONTACT

+44 (0)20 7594 3396

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bhamini Vadhwana

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23HH8340

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.