The Progression and Regression of precancerous gastric lesions: A prospective cohort study; The PROREGAL study

The second leading cause of cancer related mortality in the world is gastric
cancer. The highest incidences are found Eastern Asia, Eastern Europe and South
America and even though the incidence rate is declining, more cases are found
every year due to aging of the world population. In the Netherlands it remains
one of the most common cancers with an incidence of 2000 cases a year.
In 1992 Correa described a possible pattern of human gastric carcinogenesis.
Helicobacter Pylori is considered as the starting point of this sequence, which
leads to atrophic gastritis, intestinal metaplasia and dysplasia and eventually
ends in intestinal gastric carcinoma in 1-2%.
Since only 1-2% of the 7000 new cases with precancerous gastric lesions develop
gastric carcinoma, it is of interest which patients show progression early on,
and which patients to offer surveillance in a certain time period. Even though
it is clear that the risk of progression increases with the kind of lesion
found, it is not clear which patient progress from, for example, atrophic
gastritis to intestinal metaplasia and from intestinal metaplasia to dysplasia.
Despite previously conducted studies no consensus exists concerning H. pylori
eradication. It is not clear whether H. pylori eradication has any effect on
the progression or regression of premalignant lesions. H. pylori eradication
has shown to diminish gastritis in infected individuals and to prevent the
development of premalignant gastric lesions. However the effect on atrophy,
intestinal metaplasia or dysplasia remains a subject of discussion
An earlier retrospective study by De Vries, et al has shown that every year
0,1% of the patients with gastric atrophy, 0,25% of the patients with
intestinal metaplasia and 6% of the patients with dysplasia progress to gastric
carcinoma. The specific patients who show progression or a constant stadium of
the sequence or show regression have not been identified. It is however clear
that a combination of H. pylori virulence, host genetic factors and lifestyle
is the major part of the risk profile. When it would be possible to identify
the effect of Helicobacter pylori eradication and the specific groups of
patients with the highest risk of progression, requiring gastric cancer
screening and/ or surveillance, guidelines could be made and a uniform approach
could be created.

Identification of patients with a high risk of progression of premalignant
gastric lesions, in order to compose guidelines for surveillance and follow up.

Observational cohort study; a multicenter, prospective study. The study will be
initiated and guided by the Erasmus MC, Rotterdam. Intended participating
centers include; VU Medical Center, Amsterdam; Medical Center Leeuwarden,
Leeuwarden, Deventer Ziekenhuis, Deventer; Rijnstate Medical Center, Arnhem;
Canisius Wilhelmina Ziekenuis, Nijmegen;IJsselland Ziekenhuis, Capelle aan den
IJssel; het Sint Fransiscus Gasthuis, Rotterdam, and the AvL-NKI, Amsterdam;
Meander Medisch Centrum, Amersfoort, Maasstad ziekenhuis, Rotterdam

Patients will beasked to give a blood sample when endoscopy is performed, which
barely contains any risks for the participants. Upper gastrointestinal
endoscopy with biopsy sampling is considered to be a safe procedure and
complications are rare (1 in 3000 endoscopies).