NCT06057220|Unknown
IMaC - Immune Pathways in Oesophagogastric Cancer
IMaC
Investigation of Immune Pathways and Microbiome Disruption as Drivers of Mutagenesis in Oesophagogastric Cancer
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IMaC
Investigation of Immune Pathways and Microbiome Disruption as Drivers of Mutagenesis in Oesophagogastric Cancer
Sponsor study identifier
observational
310
1 country
3
Study Start
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 8, 2023
Actual (reported)September 28, 2023
Actual (reported)October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
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)
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.
Adult patients with known BO who are undergoing OGD for surveillance
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
Adult patients with OGc (Ac or SCc) who are having surgical resection of the cancer
No intervention
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Royal Surrey County Hospital
Guildford, GU27WG, United Kingdom
St Georges University Hospital
London, SW17 0QT, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW36JJ, United Kingdom
* Saliva * Buccal mucosa swabs * OG mucus * OG mucosal biopsies * Gastric fluid * Surgically resected specimens of primary OG tumours
First Submitted
June 8, 2023
First Posted
September 28, 2023
Study Start
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2025
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 5, 2023
Record last verified: 2023-10
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