Stomach CancerGASTRIMEDNCT02325323
Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia
An observational study of Stomach Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure. As secondary objectives, among the patients included in the cohort, the study will: assess the incidence of low grade dysplasia, assess the incidence of high grade… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Cancer
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gastric metaplasia consulting a gastroenterologist in any private or public setting in France.
Who may be able to join
- Age > 18 years.
- Gastroscopic examination with biopsy in the 6 months preceding inclusion, with intestinal metaplasia in body of stomach or angular incisure.
- Patient does not oppose to participate to the study.
Who cannot join
- Progressive concomitant disease with life expectancy less than 3 years.
- Gastric cancer at the time of inclusion.
- Patient with previous oesophageal cancer.
- Patient with previous gastric surgery.
- Anticipated obstacles to follow-up during the study (e.g., understanding difficulties, homelessness).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Hépato-gastro-Entérologie, Hôpital Ambroise Paré
Boulogne-Billancourt, Île-de-France Region, 92100
About this study
Official title: Prospective Cohort Study: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia
This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure.
As secondary objectives, among the patients included in the cohort, the study will:
- assess the incidence of low grade dysplasia,
- assess the incidence of high grade dysplasia in patients with low grade dysplasia,
- identify risk factors of progression to dysplasia and gastric cancer.
Read the detailed description
This is a French nationwide prospective study. 2000 patients will be enrolled by 3500 gastroenterologists, either in private or public healthcare settings.
All patients will undergo an endoscopy with gastric sampling in order to biopsy:
- 1 sample each in anterior and posterior surfaces of antrum
- 1 sample in lesser curvature
- 1 sample each in anterior and posterior surfaces of body of stomach
Patients will be contacted every 12 months and followed up for 3 years by their gastroenterologist. The follow-up will be performed according to the 2012 European Guideline on Management of Precancerous Conditions and Lesions in the stomach (Endoscopy 2012, Jan; 44(1): 74-94). Patients will also receive a 6-monthly phone call from their gastroenterologist in order to know if any gastric symptom has appeared. At any time, patients should contact their gastroenterologist to inform them about new gastric symptoms.
During follow-up, the frequency of gastroscopy with biopsy depends on the stage of lesions:
- patients with intestinal metaplasia: gastroscopy at 36 months.
- patients with dysplasia: an annual gastroscopy will be performed.
In case of low grade dysplasia confirmed by pathologist at inclusion, patients will undergo 1 year later another endoscopy with gastric sampling in order to biopsy:
- 4 circumferential samplings of antrum
- 1 sampling of curvature
- 4 circumferential samplings of body of stomach
- Conditions
- Stomach Cancer
- Keywords
- stomach cancer, gastric intestinal metaplasia, prospective cohort, low grade dysplasia, high grade dysplasia, prognosis factor, gastric cancer risks
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gastric cancer or high grade dysplasia of the gastric mucosa
Incidence of gastric cancer or high grade dysplasia of the gastric mucosa during the 3-year follow-up.
Measured: 3 years
Secondary outcomes (2)
Percentage of development of low grade dysplasia
Percentage of development of low grade dysplasia in patients initially with intestinal metaplasia without dysplasia.
Measured: 3 years
Percentage of development of gastric cancer or high grade dysplasia
Percentage of development in 3 years of gastric cancer or high grade dysplasia lesion, in patients initially with low grade dysplasia.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Société Nationale Française de Gastroentérologie
- Responsible party
- Sponsor
- Investigators
- Dominique LAMARQUE, MD, PhD, Principal investigator, Hôpital Ambroise Paré, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325323
- Sponsor's protocol ID
- 12-DLE-GASTRIMED
- Acronym
- GASTRIMED
- Status last verified
- Nov 2014
- First submitted
- 19 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia
- ClinicalTrials.gov ID
- NCT02325323
- Acronym / sponsor ID
- GASTRIMED / 12-DLE-GASTRIMED
- Conditions
- Stomach Cancer
- Keywords
- stomach cancer, gastric intestinal metaplasia, prospective cohort, low grade dysplasia, high grade dysplasia, prognosis factor, gastric cancer risks
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Société Nationale Française de Gastroentérologie
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 24 Dec 2014 (estimated)
- 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.
This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure.
As secondary objectives, among the patients included in the cohort, the study will:
- assess the incidence of low grade dysplasia,
- assess the incidence of high grade dysplasia in patients with low grade dysplasia,
- identify risk factors of progression to dysplasia and gastric cancer.
Detailed description
This is a French nationwide prospective study. 2000 patients will be enrolled by 3500 gastroenterologists, either in private or public healthcare settings.
All patients will undergo an endoscopy with gastric sampling in order to biopsy:
- 1 sample each in anterior and posterior surfaces of antrum
- 1 sample in lesser curvature
- 1 sample each in anterior and posterior surfaces of body of stomach
Patients will be contacted every 12 months and followed up for 3 years by their gastroenterologist. The follow-up will be performed according to the 2012 European Guideline on Management of Precancerous Conditions and Lesions in the stomach (Endoscopy 2012, Jan; 44(1): 74-94). Patients will also receive a 6-monthly phone call from their gastroenterologist in order to know if any gastric symptom has appeared. At any time, patients should contact their gastroenterologist to inform them about new gastric symptoms.
During follow-up, the frequency of gastroscopy with biopsy depends on the stage of lesions:
- patients with intestinal metaplasia: gastroscopy at 36 months.
- patients with dysplasia: an annual gastroscopy will be performed.
In case of low grade dysplasia confirmed by pathologist at inclusion, patients will undergo 1 year later another endoscopy with gastric sampling in order to biopsy:
- 4 circumferential samplings of antrum
- 1 sampling of curvature
- 4 circumferential samplings of body of stomach
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastric metaplasia consulting a gastroenterologist in any private or public setting in France.
Key inclusion criteria (3 listed)
- Age > 18 years.
- Gastroscopic examination with biopsy in the 6 months preceding inclusion, with intestinal metaplasia in body of stomach or angular incisure.
- Patient does not oppose to participate to the study.
Key exclusion criteria (5 listed)
- Progressive concomitant disease with life expectancy less than 3 years.
- Gastric cancer at the time of inclusion.
- Patient with previous oesophageal cancer.
- Patient with previous gastric surgery.
- Anticipated obstacles to follow-up during the study (e.g., understanding difficulties, homelessness).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of gastric cancer or high grade dysplasia of the gastric mucosa
Time frame: 3 years
Incidence of gastric cancer or high grade dysplasia of the gastric mucosa during the 3-year follow-up.
2 secondary outcomes
Percentage of development of low grade dysplasia
Time frame: 3 years
Percentage of development of gastric cancer or high grade dysplasia
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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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.
Dominique LAMARQUE, MD, PhD principal investigator
Hôpital Ambroise Paré, APHP
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 Stomach Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 5 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 24 Dec 2014. 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 France. 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?
Contact Dominique LAMARQUE, MD, PhD (+33 1 49 09 53 25, dominique.lamarque@apr.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gastric cancer or high grade dysplasia of the gastric mucosa (time frame: 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 24 Dec 2014.