Gastric CancerNCT03250091
Surveillance of Patients With Precancerous Lesions of the Stomach
An observational study of Gastric Cancer and Gastric Intestinal Metaplasia, run by University of Latvia at 1 site in Latvia.
Trial summary
The project will aim to identify and determine subgroups of patients with different risks of progression to gastric cancer and to assess appropriate follow-up intervals. Implementing risk stratification only high risk individuals will be offered and performed endoscopic surveillance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Gastric Intestinal Metaplasia, Gastric Atrophy
- What is being tested?
- Upper endoscopy with biopsies, Plasma/serum sampling and Biopsies for gastric microbiota
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteLatvia
- Study dates
- 19 Jun 2017to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients with material of standardized biopsies according to the standard criteria (updated Sydney system) will be classified in different risk groups for progression to gastric cancer (Group 2-7). The appropriate follow-up intervals will be scheduled according MAPS guidelines and follow-up procedures (upper endoscopies) will be performed for each research group (Group 2-7).
Who may be able to join
- Patients undergoing upper endoscopy Motivation to participate in the study Signed consent
Who cannot join
- Known gastric cancer Unwillingness or inability to co-operate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Latvia1 site, 1 recruiting
- Recruiting
University of Latvia
Riga, LV 1586
Ilze Kikuste, PhD, +317 28357349, ikikuste@gmail.com
Marcis Leja, Prof., PhD, marcis.leja@lu.lv
About this study
Official title: Surveillance Strategies of Patients With Precancerous Conditions and Lesions in the Stomach
The project will aim to identify and determine subgroups of patients with different risks of progression to gastric cancer and to assess appropriate follow-up intervals. Implementing risk stratification only high risk individuals will be offered and performed endoscopic surveillance.
Read the detailed description
Gastric cancer is still an important healthcare problem with significant mortality rates. Latvia is a high incidence country of gastric cancer. Unfortunately most of the gastric cancer cases in Latvia are diagnosed at late stages when the treatment is substantially less effective.
Ideally, gastric cancer could be prevented by detecting gastric precancerous conditions/lesions and identifying those individuals at high-risk of progressing to cancer to the follow-up.
Population based endoscopic screening for gastric cancer is not recommended for the early detection of gastric cancer generally deemed not to be cost-effective.
However, in the absence of screening, patients present with advanced disease, and prognosis is poor.
Targeted endoscopic surveillance strategies for gastric cancer should be introduced following the principles of the recent European guidelines: Management of precancerous conditions and lesions in the stomach (MAPS) (Dinis-Ribeiro, Areia et al. 2012).
The project will aim to identify and determine subgroups of patients with different risks of progression to gastric cancer and to assess appropriate follow-up intervals. Implementing risk stratification only high risk individuals will be offered endoscopic surveillance.
- Being tested
- Upper endoscopy with biopsies, Plasma/serum sampling, Biopsies for gastric microbiota, Faecal sample acquisition
- Keywords
- gastric precancerous lesions, gastric cancer, gastric intestinal Metaplasia, gastric atrophy, gastric dysplasia
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper endoscopy with biopsiesProcedure or surgery
Also called gastroscopy, upper endoscopy
Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection
Plasma/serum samplingProcedure or surgery
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
Biopsies for gastric microbiotaProcedure or surgery
During upper endoscopy biopsies for gastric microbiota analysis will be obtained
Faecal sample acquisitionProcedure or surgery
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer | Gastric adenocarcinoma and other gastric malignancies Receives: Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Biopsies for gastric microbiota; Procedure: Faecal sample acquisition | |
| Gastric mucosal dysplasia | Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia Receives: Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Biopsies for gastric microbiota; Procedure: Faecal sample acquisition | |
| High-risk IM gastritis stages | High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III. Receives: Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Biopsies for gastric microbiota; Procedure: Faecal sample acquisition | |
| High-risk atrophic gastritis stages | High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III. Receives: Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Biopsies for gastric microbiota; Procedure: Faecal sample acquisition | |
| Extensive gastric intestinal metaplasia | Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV). Receives: Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Biopsies for gastric microbiota; Procedure: Faecal sample acquisition | |
| Extensive atrophy | Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV. Receives: Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Biopsies for gastric microbiota; Procedure: Faecal sample acquisition | |
| Isolated corpus atrophy | Isolated moderate-to-severe atrophy or IM in the corpus. Receives: Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Biopsies for gastric microbiota; Procedure: Faecal sample acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk stratification
The patients with material of standardized biopsies according to the standard criteria (updated Sydney system) will be classified in different risk groups for progressing to gastric cancer.
The measurements for the risk stratification will be used following the updated Sydney grading and classification system e.g. degree and extent of atrophy, intestinal metaplasia and dysplasia in the stomach mucosa
Measured: At baseline
Secondary outcomes (2)
Scheduled follow-up procedures (gastroscopies) for high risk group patients
The subgroup of patients at different risk of progression to gastric cancer will be selected and appropriate follow-up intervals will be scheduled and performed. Significant risk stage changes before and after the follow-up upper endoscopy in different research groups.
Measured: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion
Gastric, faecal microbiome in cancer patients and patients with precancerous lesions
Significant differences in the composition of gastric, faecal microbiome (phyla, genera) in cancer patients and patients with precancerous lesions
Measured: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start19 Jun 2017
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Latvia
- Sponsor type
- University, hospital or other
- Collaborators
- Digestive Diseases Centre GASTRO, Riga East Clinical University Hospital, Academic Histology Laboratory (Latvia)
- Responsible party
- Sponsor
- Investigators
- Marcis Leja, Prof.,PhD, Study director, Institute of Clinical and Preventive Medicine, University of Latvia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250091
- Sponsor's protocol ID
- 2915
- Status last verified
- Aug 2018
- First submitted
- 21 Jul 2017
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dinis-Ribeiro M, Areia M, de Vries AC, Marcos-Pinto R, Monteiro-Soares M, O'Connor A, Pereira C, Pimentel-Nunes P, Correia R, Ensari A, Dumonceau JM, Machado JC, Macedo G, Malfertheiner P, Matysiak-Budnik T, Megraud F, Miki K, O'Morain C, Peek RM, Ponchon T, Ristimaki A, Rembacken B, Carneiro F, Kuipers EJ; European Society of Gastrointestinal Endoscopy; European Helicobacter Study Group; European Society of Pathology; Sociedade Portuguesa de Endoscopia Digestiva. Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED). Endoscopy. 2012 Jan;44(1):74-94. doi: 10.1055/s-0031-1291491. Epub 2011 Dec 23.
PubMed 22198778
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Strategies of Patients With Precancerous Conditions and Lesions in the Stomach
- ClinicalTrials.gov ID
- NCT03250091
- Acronym / sponsor ID
- 2915
- Keywords
- gastric precancerous lesions, gastric cancer, gastric intestinal Metaplasia, gastric atrophy, gastric dysplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of LatviaUniversity, hospital or other
- Collaborators
- Digestive Diseases Centre GASTRO, Riga East Clinical University Hospital, Academic Histology Laboratory (Latvia)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Aug 2017 (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 project will aim to identify and determine subgroups of patients with different risks of progression to gastric cancer and to assess appropriate follow-up intervals. Implementing risk stratification only high risk individuals will be offered and performed endoscopic surveillance.
Detailed description
Gastric cancer is still an important healthcare problem with significant mortality rates. Latvia is a high incidence country of gastric cancer. Unfortunately most of the gastric cancer cases in Latvia are diagnosed at late stages when the treatment is substantially less effective.
Ideally, gastric cancer could be prevented by detecting gastric precancerous conditions/lesions and identifying those individuals at high-risk of progressing to cancer to the follow-up.
Population based endoscopic screening for gastric cancer is not recommended for the early detection of gastric cancer generally deemed not to be cost-effective.
However, in the absence of screening, patients present with advanced disease, and prognosis is poor.
Targeted endoscopic surveillance strategies for gastric cancer should be introduced following the principles of the recent European guidelines: Management of precancerous conditions and lesions in the stomach (MAPS) (Dinis-Ribeiro, Areia et al. 2012).
The project will aim to identify and determine subgroups of patients with different risks of progression to gastric cancer and to assess appropriate follow-up intervals. Implementing risk stratification only high risk individuals will be offered endoscopic surveillance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer | – | Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Biopsies for gastric microbiota, Procedure: Faecal sample acquisitionGastric adenocarcinoma and other gastric malignancies |
| Gastric mucosal dysplasia | – | Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Biopsies for gastric microbiota, Procedure: Faecal sample acquisitionIncludes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia |
| High-risk IM gastritis stages | – | Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Biopsies for gastric microbiota, Procedure: Faecal sample acquisitionHigh-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III. |
| High-risk atrophic gastritis stages | – | Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Biopsies for gastric microbiota, Procedure: Faecal sample acquisitionHigh-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III. |
| Extensive gastric intestinal metaplasia | – | Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Biopsies for gastric microbiota, Procedure: Faecal sample acquisitionIntestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV). |
| Extensive atrophy | – | Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Biopsies for gastric microbiota, Procedure: Faecal sample acquisitionModerate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV. |
| Isolated corpus atrophy | – | Procedure: Upper endoscopy with biopsies, Procedure: Plasma/serum sampling, Procedure: Biopsies for gastric microbiota, Procedure: Faecal sample acquisitionIsolated moderate-to-severe atrophy or IM in the corpus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with material of standardized biopsies according to the standard criteria (updated Sydney system) will be classified in different risk groups for progression to gastric cancer (Group 2-7). The appropriate follow-up intervals will be scheduled according MAPS guidelines and follow-up procedures (upper endoscopies) will be performed for each research group (Group 2-7).
Key inclusion criteria (1 listed)
- Patients undergoing upper endoscopy Motivation to participate in the study Signed consent
Key exclusion criteria (1 listed)
- Known gastric cancer Unwillingness or inability to co-operate
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 |
|---|---|---|
| Upper endoscopy with biopsiesAlso: gastroscopy, upper endoscopyUpper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection | Procedure or surgery | Extensive atrophy, Extensive gastric intestinal metaplasia, Gastric cancer, Gastric mucosal dysplasia, High-risk IM gastritis stages, High-risk atrophic gastritis stages, Isolated corpus atrophy |
| Plasma/serum samplingPlasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers | Procedure or surgery | Extensive atrophy, Extensive gastric intestinal metaplasia, Gastric cancer, Gastric mucosal dysplasia, High-risk IM gastritis stages, High-risk atrophic gastritis stages, Isolated corpus atrophy |
| Biopsies for gastric microbiotaDuring upper endoscopy biopsies for gastric microbiota analysis will be obtained | Procedure or surgery | Extensive atrophy, Extensive gastric intestinal metaplasia, Gastric cancer, Gastric mucosal dysplasia, High-risk IM gastritis stages, High-risk atrophic gastritis stages, Isolated corpus atrophy |
| Faecal sample acquisitionFaecal samples will be obtained for faecal occult blood testing as well as microbiota analysis | Procedure or surgery | Extensive atrophy, Extensive gastric intestinal metaplasia, Gastric cancer, Gastric mucosal dysplasia, High-risk IM gastritis stages, High-risk atrophic gastritis stages, Isolated corpus atrophy |
Primary outcome
Risk stratification
Time frame: At baseline
The patients with material of standardized biopsies according to the standard criteria (updated Sydney system) will be classified in different risk groups for progressing to gastric cancer. The measurements for the risk stratification will be used following the updated Sydney grading and classification system e.g. degree and extent of atrophy, intestinal metaplasia and dysplasia in the stomach mucosa
2 secondary outcomes
Scheduled follow-up procedures (gastroscopies) for high risk group patients
Time frame: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion
Gastric, faecal microbiome in cancer patients and patients with precancerous lesions
Time frame: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Background: PubMed 22198778Dinis-Ribeiro M, Areia M, de Vries AC, Marcos-Pinto R, Monteiro-Soares M, O'Connor A, Pereira C, Pimentel-Nunes P, Correia R, Ensari A, Dumonceau JM, Machado JC, Macedo G, Malfertheiner P, Matysiak-Budnik T, Megraud F, Miki K, O'Morain C, Peek RM, Ponchon T, Ristimaki A, Rembacken B, Carneiro F, Kuipers EJ; European Society of Gastrointestinal Endoscopy; European Helicobacter Study Group; European Society of Pathology; Sociedade Portuguesa de Endoscopia Digestiva. Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED). Endoscopy. 2012 Jan;44(1):74-94. doi: 10.1055/s-0031-1291491. Epub 2011 Dec 23.
- 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.
Marcis Leja, Prof.,PhD study director
Institute of Clinical and Preventive Medicine, University of Latvia
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 and Gastric Intestinal Metaplasia, run by University of Latvia at 1 site in Latvia.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 2018. 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 Latvia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilze Kikuste, PhD (28357349 ext. +371, ikikuste@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk stratification (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03250091, which also lists 1 linked publication.
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 21 Aug 2018.