Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery

Gastric Adenocarcinoma Clinical Trial

— LABS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289374
• Other study ID #: 23HH8340
• Status: Recruiting
• Start date: April 2024
• Est. completion date: June 2029

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: Bhamini Vadhwana, MRCS, PhD
• Phone: +44 (0)20 7594 3396
• Email: b.vadhwana[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2029
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma
• Oesophageal Adenocarcinoma

Intervention

Other:
• Biosample collection
Collection of saliva, urine, blood, breath and quality of life questionnaires.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 months
Secondary	Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment	Changes in the VOC profile using gas chromatography mass spectrometry.	48 months
Secondary	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.	48 months