IMaC - Immune Pathways in Oesophagogastric Cancer

NCT06057220 | Not Yet Recruiting

• 1 other identifier: CCR5791
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Oesophagogastric Cancer

Outcome Measures

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.

  Through study completion (an average of 3 years)

Secondary Outcomes (3)

• Characterise and compare the microbiome and mucin profiles of the oropharynx

  Through study completion (an average of 3 years)

• Determine concomitant alterations in mucosal immune pathways and mucus biology

  Through study completion (an average of 3 years)

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

  Through study completion (an average of 3 years)

Study Arms (4)

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.

Other: No intervention sample collection only

Group 2

Adult patients with known BO who are undergoing OGD for surveillance

Other: No intervention sample collection only

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

Other: No intervention sample collection only

Group 4

Adult patients with OGc (Ac or SCc) who are having surgical resection of the cancer

Other: No intervention sample collection only

Interventions

No intervention sample collection only OTHER

No intervention

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Barrett's oesophagus (BO) requiring surveillance or endoscopic therapy.
• Histologically confirmed OGc undergoing further investigation as part of staging such as laparoscopy and OGD or undergoing surgical resection (oesophagectomy/gastrectomy) as part of their treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Imperial College London: collaborator

Study Sites (3)

Royal Surrey County Hospital

Guildford, GU27WG, United Kingdom

Location

St Georges University Hospital

London, SW17 0QT, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW36JJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Saliva * Buccal mucosa swabs * OG mucus * OG mucosal biopsies * Gastric fluid * Surgically resected specimens of primary OG tumours

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: September 28, 2023
• Study Start: October 1, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)