Gastric CancerNCT06305169
Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer
An observational study of Gastric Cancer, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Gastropanel
- How many people
- 440 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2024to 1 Jul 2024
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of those patients referred primarily from their general practice for a cancer pathway endoscopy at the study site.
Who may be able to join
- Patients referred for a 2 week wait cancer pathway endoscopy for the following indications Or Upper abdominal mass consistent with stomach cancer Or Stable upper gastrointestinal bleeding Or
- Aged 55 and over with weight loss and any of the following:
- Upper abdominal pain
- Reflux
- Dyspepsia
Who cannot join
- Referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion)
- Previous gastro-duodenal surgery,
- Any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sandwell General Hospital
Birmingham, West Midlands, B71 4HJ
About this study
Official title: Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer Along With Creating a Predictive Model for the Identification of Patients That Need Urgent Endoscopy
Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis.
The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad.
Read more
To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy.
A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- Gastropanel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastropanelDiagnostic test
Gastropanel is a commercially available blood test which given serum levels of pepsinogen I and II and gastrin 17 along with helicobacter pylori infection status
| Study group | Role | What they receive |
|---|---|---|
| Referrals to endoscopy via the 2 week wait cancer pathway for all indications other than dysphagia | This group will have their serum biomarkers measured by gastropanel a commercially available blood test, along with full blood count and complete a questionnaire. Receives: Diagnostic Test: Gastropanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the specificity and negative predictive value of serum biomarkers in gastric cancer
Gastric serum biomarkers measured by gastropanel will be measured in 400 patients who undergo endoscopy. The research team will measure the specificity and negative predictive value of gastropanel in excluding gastric cancer in patient enrolled into the study.
Measured: 12 months
Secondary outcomes (1)
Creating a scoring system for patients that warrant urgent endoscopy on the cancer pathway
By using the hormone levels detected in the gastropanel blood test along with a blood test to check for anaemia (low red blood count), patient questionnaire looking at symptoms and the patients medical background the research team will use logistic regression analysis to identify factors strongly associated with cancer diagnosis and derive a risk score.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nigel Trudgill, Sandwell & West Birmingham Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305169
- Sponsor's protocol ID
- 1.4
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised aggregated data can be requested by other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer Along With Creating a Predictive Model for the Identification of Patients That Need Urgent Endoscopy
- ClinicalTrials.gov ID
- NCT06305169
- Acronym / sponsor ID
- 1.4
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 12 Mar 2024 (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.
Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis.
The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad.
To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy.
A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Referrals to endoscopy via the 2 week wait cancer pathway for all indications other than dysphagia | – | Diagnostic Test: GastropanelThis group will have their serum biomarkers measured by gastropanel a commercially available blood test, along with full blood count and complete a questionnaire. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of those patients referred primarily from their general practice for a cancer pathway endoscopy at the study site.
Key inclusion criteria (5 listed)
- Patients referred for a 2 week wait cancer pathway endoscopy for the following indications Or Upper abdominal mass consistent with stomach cancer Or Stable upper gastrointestinal bleeding Or
- Upper abdominal pain
- Reflux
- Dyspepsia
Key exclusion criteria (3 listed)
- Referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion)
- Previous gastro-duodenal surgery,
- Any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease)
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 |
|---|---|---|
| GastropanelGastropanel is a commercially available blood test which given serum levels of pepsinogen I and II and gastrin 17 along with helicobacter pylori infection status | Diagnostic test | Referrals to endoscopy via the 2 week wait cancer pathway for all indications other than dysphagia |
Primary outcome
Measurement of the specificity and negative predictive value of serum biomarkers in gastric cancer
Time frame: 12 months
Gastric serum biomarkers measured by gastropanel will be measured in 400 patients who undergo endoscopy. The research team will measure the specificity and negative predictive value of gastropanel in excluding gastric cancer in patient enrolled into the study.
1 secondary outcome
Creating a scoring system for patients that warrant urgent endoscopy on the cancer pathway
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No. Anonymised aggregated data can be requested by other researchers
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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 record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site 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 5 inclusion and 3 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the specificity and negative predictive value of serum biomarkers in gastric cancer (time frame: 12 months). 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 12 Mar 2024.