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IMaC - Immune Pathways in Oesophagogastric Cancer

ConditionOesophagogastric Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age17+
SponsorRoyal Marsden NHS Foundation Trust

About this trial

The number of cases of oesophagogastric cancer is increasing every year. Currently, only 39% of patients with oesophageal cancer can have potentially curative treatment by the time they are diagnosed. This is because it typically presents late, and it is only when patients start to develop symptoms of advanced disease such as difficulty swallowing and weight loss, that they seek medical attention.

There are approximately 9300 new cases of oesophageal cancer in the UK each year and at 17%, it has the 5th poorest 5-year survival of all cancers in the UK.

It is diagnosed by carrying out a camera test called a gastroscopy which allows a biopsy of the cancer to be taken. This is an invasive procedure, and unlike for other types of cancer, such as bowel cancer, there is no test to risk-stratify patients at an earlier stage. Risk-stratification enables patients more likely to develop oesophagogastric cancer to be identified, which allows them to have more focused follow-up. This can potentially enable cancer to be diagnosed earlier, before the disease becomes more advanced, allowing patients to have potentially curative treatment.

Scientific research has identified that the healthy bacteria in the oesophagus and stomach changes as oesophagogastric cancer develops. The investigators want to see if similar changes can be identified in the healthy bacteria in the mouth which could be indicative of cancer developing in the oesophagus or stomach. The investigators then hope to use this information to develop a non-invasive risk-stratification tool that can be used to diagnose oesophagogastric cancer earlier and thereby enable more patients to be cured.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients >16 years old

Referred for oesophago-gastro-duodenoscopy (OGD) to investigate any of the following;

Symptoms including difficulty swallowing, vomiting, reflux symptoms including heartburn, anaemia, GI bleeding, upper abdominal pain and weight loss.

Oesophagitis, gastritis or GORD.

Disqualifiers

Cancers other than adenocarcinoma or squamous cell carcinoma, including but not limited to gastro-intestinal stromal tumours (GIST), mucosa associated lymphoid tissue lymphoma (MALT lymphoma) and carcinoid tumours.

Patients with recurrent OGc.

Trial population

1. Group 1 - Adult patients referred for oesophago-gastro-duodenoscopy (OGD) to investigate any of the following symptoms: difficulty swallowing, vomiting, reflux, anaemia, gastrointestinal (GI) bleeding, upper abdominal pain and weight loss. 2. Group 2 - Adult patients with known BO who are undergoing OGD for surveillance. 3. Group 3 - Adult patients who have been diagnosed with OGc (Ac or SCc) and are having further investigations as part of the disease staging process such as a staging laparoscopy or further OGD. 4. Group 4 - Adult patients with OGc (Ac or SCc) who are having surgical resection of the cancer.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention sample collection only

    Other intervention

    No intervention

Treatment groups

310 Participants
are divided into 4 treatment groups
Group A: Group 11 intervention
Group B: Group 21 intervention
Group C: Group 31 intervention
Group D: Group 41 intervention

Trial outcomes

Primary outcomes

1

Derive biomarker(s) from the oropharyngeal microbiome and mucin profiles in each patient cohort

Identification of a novel biomarker detectable in salivary samples or buccal swabs from the oropharynx, that can be used as a marker of downstream neoplastic changes leading to oesophagogastric carcinoma.

Time frame
Through study completion (an average of 3 years)

Secondary outcomes

1

Characterise and compare the microbiome and mucin profiles of the oropharynx

Profile the oropharyngeal microbiome and mucin perturbations occurring across the spectrum of pre-malignant oesophgagogastic disease (Barrett's Oesophagus) and oesophagogastric cancers, including controls with no endoscopic evidence of upper Gastrointestinal (GI) pathology i.e. a normal upper GI tract, negative Helicobacter pylori tests and patients with GORD

Time frame
Through study completion (an average of 3 years)
2

Determine concomitant alterations in mucosal immune pathways and mucus biology

Comprehensive understanding of altered immune pathways driving oesophageal cancer and their relation to microbiota and mucus perturbations to provide targets for mechanistic investigation within experimental models

Time frame
Through study completion (an average of 3 years)
3

Establish causation between microbiome/immune/mucin perturbation and carcinogenesis.

Gain understanding of key pathways driving oesophageal carcinogenesis, insights that are essential for developing robust biologically-plausible early biomarkers with high clinical predictive value, through the use of in vitro models

Time frame
Through study completion (an average of 3 years)

Other outcomes

Sponsors and contacts

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

Royal Marsden NHS Foundation Trust

Lead sponsor

Imperial College London

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: