Oesophagogastric CancerIMaCNCT06057220
IMaC - Immune Pathways in Oesophagogastric Cancer
An observational study of Oesophagogastric Cancer, run by Royal Marsden NHS Foundation Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Oesophagogastric Cancer
- How many people
- 310 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Oct 2023to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Royal Surrey County Hospital
Guildford, GU27WG
St Georges University Hospital
London, SW17 0QT
Subhir Bedi, researchgovernance@sgul.ac.uk
Chris Groves
The Royal Marsden NHS Foundation Trust
London, SW36JJ
Mark Brandon-Grove, 02031865416, Mark.Brandon-Grove@rmh.nhs.uk
Sacheen Kumar
About this study
Official title: Investigation of Immune Pathways and Microbiome Disruption as Drivers of Mutagenesis in Oesophagogastric Cancer
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.
Read more
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.
Read the detailed description
The purpose of this study is to investigate the interplay between immune pathways, the mucosal barrier and microbiome in oesophagogastric cancer, with the intention of identifying biologically-plausible biomarkers implicated in oesophagogastric carcinogenesis. The long-term translational objective of this work is to develop a non-invasive risk-stratification test with the aim of identifying patients at risk of developing, or with possible early oesophagogastric cancer, who can then undergo diagnostic testing with the intention of identifying early, potentially curable disease.
In order to do this, a deep understanding of the microbiome, the immune pathways, and ensuing changes at the level of the oesophagogastric mucosa is required. This work aligns with one of the cornerstones of improving survival in OGc; early diagnosis.
- Conditions
- Oesophagogastric Cancer
- Being tested
- No intervention sample collection only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention sample collection onlyOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention sample collection only | |
| Group 2 | Adult patients with known BO who are undergoing OGD for surveillance Receives: 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 Receives: Other: No intervention sample collection only | |
| Group 4 | Adult patients with OGc (Ac or SCc) who are having surgical resection of the cancer Receives: Other: No intervention sample collection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion (an average of 3 years)
Secondary outcomes (3)
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
Measured: Through study completion (an average of 3 years)
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
Measured: Through study completion (an average of 3 years)
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
Measured: Through study completion (an average of 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophagogastric CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057220
- Sponsor's protocol ID
- CCR5791
- Acronym
- IMaC
- Status last verified
- Oct 2023
- First submitted
- 8 Jun 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Immune Pathways and Microbiome Disruption as Drivers of Mutagenesis in Oesophagogastric Cancer
- ClinicalTrials.gov ID
- NCT06057220
- Acronym / sponsor ID
- IMaC / CCR5791
- Conditions
- Oesophagogastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- Oct 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to investigate the interplay between immune pathways, the mucosal barrier and microbiome in oesophagogastric cancer, with the intention of identifying biologically-plausible biomarkers implicated in oesophagogastric carcinogenesis. The long-term translational objective of this work is to develop a non-invasive risk-stratification test with the aim of identifying patients at risk of developing, or with possible early oesophagogastric cancer, who can then undergo diagnostic testing with the intention of identifying early, potentially curable disease.
In order to do this, a deep understanding of the microbiome, the immune pathways, and ensuing changes at the level of the oesophagogastric mucosa is required. This work aligns with one of the cornerstones of improving survival in OGc; early diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No intervention sample collection onlyAdult 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. |
| Group 2 | – | Other: No intervention sample collection onlyAdult patients with known BO who are undergoing OGD for surveillance |
| Group 3 | – | Other: No intervention sample collection onlyAdult 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 |
| Group 4 | – | Other: No intervention sample collection onlyAdult patients with OGc (Ac or SCc) who are having surgical resection of the cancer |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Adult patients >16 years old
- Referred for oesophago-gastro-duodenoscopy (OGD) to investigate any of the following;
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention sample collection onlyNo intervention | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Derive biomarker(s) from the oropharyngeal microbiome and mucin profiles in each patient cohort
Time frame: Through study completion (an average of 3 years)
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.
3 secondary outcomes
Characterise and compare the microbiome and mucin profiles of the oropharynx
Time frame: Through study completion (an average of 3 years)
Determine concomitant alterations in mucosal immune pathways and mucus biology
Time frame: Through study completion (an average of 3 years)
Establish causation between microbiome/immune/mucin perturbation and carcinogenesis.
Time frame: Through study completion (an average of 3 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Royal Marsden NHS Foundation Trust
London, United Kingdom
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophagogastric Cancer, run by Royal Marsden NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Derive biomarker(s) from the oropharyngeal microbiome and mucin profiles in each patient cohort (time frame: Through study completion (an average of 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.