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Development of a methodology for the screening and detection of early gastric cancer

Aim: to develop, manufacture and market a system of three
diagnostic test kits (pepsinogen i, gastrin 17, helicobacter
pylori) for the identification of symptom-free individuals
at high risk or those with an early stage gastric cancer.

General Gastric cancer is one of the most common malignancies worldwide. The prognosis of gastic cancer is, however, poor since the late appearance of the symptoms delays the patients from seeking medical treatment. At the moment, the only successful treatment is early diagnosis and total removal of the tumor by surgery. However, the early detection of gastic cancer is difficult and in most Western countries the five year survival rate is less than 20%. It has been shown that a strong positive correlation exists between chronic atrophic gastritis and gastric cancer. Men suffering from severe atrophic gastritis have a 4-5 times higher risk of developing gastric cancer than the general population. In chronic atrophic gastritis of the antrum area, the risk is 20 times higher and in chronic atrophic pan gastritis 90 times higher than that of the general population. Biological markers for the risk of gastric cancer - serum Pepsinogen I (S-PG I) concentration reflects the number of pepsinogen-secreting cells in the corpus area. In atropic corpus gastritis the concentration of S-PG I decreases, whereas the pepsinogen II concentration stays normal. The more severe the atrophy, the lower the S-PG I concentration. Severe atrophic corpus gastritis can be diagnosed by measuring the S-PG I concentrations with more than 90% sensitivity and 98% specificity. Atrophy in the antrum area cannot, however, be detected by measuring S-PG I concentrations. - G-cells in the antrum and duodenum are responsible for the gastrin secretion. Gastrin is secreted into the gastrointestinal tract in three different forms: Gastrin-14, Gastrin-17 and Gastrin-34. Over 90% of the gastrin secreted from the human antrum is gastrin-17, whereas duodenal gastrin is mainly gastrin-34. In atrophic antral gastritis, the secretion of gastrin-17 should decrease and its concentration in serum should diminish. Therefore, the low serum gastrin-17 (S-G 17) concentration would indicate atrophy and hence the increased risk of gastric cancer. - helicobacter pylori (H.pylori) is a gram negative bacteria in the gastric mucosa. This bacteria causes an inflammatory reaction in the gastric mucosal membrane. It has been shown that 70-90% of patients suffering from chronic gastritis have an H.pylori infection. Since H-pylori infection and chronic gastritis are very closely connected, it is possible that this infection might be an etiological factor for gastric cancer. Furthermore, there have been postulations that the carcinogenic potential may be confined to certain strains of H.pylori, possibly the cytotoxin-producing ones. Indeed, strains expressing the cytotoxin-associated antigen were found to be more common in infected gastric cancer patients than in infected controls. The combination of these three potential "markers" for atrophic gastritis and hence of the risk of developing gastric cancer brings new information both on the site and the stage of a possible atrophy, thus giving new dimensions to predicting, preventing and curing early gastric cancers. The aim of the project The aim of the project is to develop a diagnostic methodology, which would easily and cost effectively detect those symptom-free individuals at risk from gastric cancer. Those at risk should undergo a gastroscopic examination and if pre-malignant changes in the mucosa are found, follow up examinations should be conducted at regular intervals. Since atrophic gastritis is a risk factor for gastric cancer, the aim is achieved by developing a screening test system for gastric atrophy. The most suitable method would be a test panel consisting of the above-mentioned "markers", that is: S-PG I, S-G 17 and H.pylori IgG. In the first stage, these three assays will be developed to commercial products based on non-radioactive, microplate formatted, enzyme immuno assay (EIA) technology, to be complemented later on by fast "bedside type" tests utilising the dot blot and immuno blot technology.
Acronym: 
CANCER SCREEN
Project ID: 
1 730
Start date: 
01-08-1996
Project Duration: 
44months
Project costs: 
620 000.00€
Technological Area: 
Market Area: 

Raising the productivity and competitiveness of European businesses through technology. Boosting national economies on the international market, and strengthening the basis for sustainable prosperity and employment.