Study on the Early Detection of Precancerous Lesions and Cancer of the Esophagus and Stomach in People at Increased Risk (RISC-VAL)

Stomach and esophageal cancer (gastric carcinoma, esophageal carcinoma) are malignant tumors that can develop in the lining of the stomach or esophagus. Risk factors include, among others, persistent heartburn (gastroesophageal reflux disease), certain precancerous conditions such as mucosal changes (e.g., Barrett’s esophagus), infection with the bacterium Helicobacter pylori (which causes infections of the stomach lining), smoking, alcohol consumption, a family history of the disease, and certain genetic traits. Being overweight and a diet low in fiber can also increase the risk. The difficulty in diagnosing stomach and esophageal cancer lies in the fact that early stages often cause no symptoms or only nonspecific symptoms, which is why many tumors are not detected until a late stage. When symptoms do occur, they often include difficulty swallowing, persistent heartburn, unintentional weight loss, loss of appetite, a feeling of fullness, or nausea. In later stages, more severe difficulty swallowing, blood in the stool or vomit, significant weight loss, and general weakness may also occur. In these advanced stages, the chances of a cure are usually significantly lower. If detected early, however, many of these tumors could be effectively treated or even completely removed. To date, there are no early detection programs for stomach or esophageal cancer, such as those that already exist for colorectal or breast cancer.

The goal of this RISC-VAL validation study is to investigate whether preventive esophagoscopy and gastroscopy in people at high risk of developing stomach and esophageal cancer help detect early changes or cancer in the upper gastrointestinal tract and improve the prognosis of treatment. To assess risk, the so-called Risk Score 1 (RS1) was developed in an earlier study; it is based on personal characteristics and risk factors (e.g., age, pre-existing conditions, lifestyle). This score helps assess an individual’s risk of developing such cancers.

Based on this risk score, the current study is now examining whether targeted early-detection screening is appropriate and reliable for individuals at higher risk. The risk is not determined within the RISC-VAL study itself, but rather in advance via a separate questionnaire (RS1 risk score). The RISC-VAL study then evaluates this approach: Only individuals with an elevated risk according to the score are invited to undergo a gastroscopy (esophagogastroduodenoscopy, EGD). The aim is to determine whether this targeted two-step screening strategy helps to reliably and promptly detect precancerous lesions or early-stage tumors without unnecessarily burdening many low-risk individuals.

Only participants with a high RS1 score are enrolled in the RISC-VAL study. They undergo an esophagogastroduodenoscopy (EGD), during which tissue samples are taken and examined. Based on the examination results, a second risk score (RS2) is calculated to assess how well the initial assessment (RS1) contributes to early detection. The primary endpoint of the study is to demonstrate that this risk-based screening EGDS is effective and acceptable for high-risk individuals—that is, that it reliably helps detect early precancerous lesions or cancer in the upper gastrointestinal tract at an early stage, thereby improving the chances of cure. As part of a companion study, researchers are examining how reliably the previously developed risk score (RS1) can predict possible precancerous lesions or early-stage forms of stomach or esophageal cancer. To this end, data will be analyzed from patients who underwent a gastroscopy (esophagogastroduodenoscopy, OGD) as part of their regular medical care. The goal of this supplementary study is to determine how many people, despite having a normal or low risk score (non-high RS1), show abnormal findings during the endoscopy—that is, signs of precancerous lesions or malignant changes. This information will help further evaluate the reliability and safety of the RS1 score and improve it if necessary.

Women and men aged 50 to 75 are eligible to participate in the study. Patients must not have any diseases of the upper gastrointestinal tract and must not have undergone an OGD within the last three years. Patients with known polyposis or Lynch syndrome are also excluded from participation.