Health TrialsbyHealthPanel

Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery

ConditionsOesophageal AdenocarcinomaGastric Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorImperial College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-90 years at the time of initial recruitment

Gastric/oesophageal adenocarcinoma cohort (biopsy proven adenocarcinoma) recruited into BIORESOURCE 1

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Biosample collection

    Other intervention

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: The LABS study (Bioresource 2: Longitudinal)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
48 months

Secondary outcomes

1

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

Changes in the VOC profile using gas chromatography mass spectrometry.

Time frame
48 months
2

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.

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Cancer Research UK

Collaborator

Source ClinicalTrials.gov
Apply now