The Familial Gastric Cancer Study (FGCS) launched in [year] aims to discover more about factors that influence the risk of stomach cancer in people with a family history of diffuse-type gastric cancer and identify how best to monitor and manage individuals at higher risk of this disease.
This updated study is a continuation of the Familial Gastric Cancer Study set up in 1997 by Professor Carlos Caldas originally to collect information and blood samples from families with clustered cases of gastric cancer in the UK. This most recent version of the study takes into account researchers’ new understanding of Hereditary Diffuse Gastric Cancer (HDGC) and the availability of new research technologies.
Individuals who wish to participate in the Familial Gastric Cancer Study must fulfil the criteria HDGC. Their eligibility will be assessed by the clinical team at Cambridge University Hospitals, and they can choose to continue their standard-of-care at Addenbrookes Hospital, under the research facility on the Biomedical Campus.
Those who were recruited to the previous FGCS will be able to join this new study, as long as they provide their written consent, and their data would be transferred accordingly to ensure continuity.
Information for patients
Potential participants will usually be referred to the FGCS via their genetic counsellor after they have been identified with a pathogenic gene mutation (CDH1 or CTNNA1) which pre-disposes them to a greater risk of developing diffuse-type gastric cancer. An individual can also be referred if they have fulfilled genetic testing criteria, but no pathogenic gene variant has been identified - this is described as ‘HDGC-like’.
The individual would be asked for details about any cancers running in the family and may be asked for permission to request additional information from their clinicians about their family history including confirmations of cancer pathologies and their own medical history including genetic test results.
If the individual is eligible to participate in the study, they will be approached by a member of the research team for their written consent.
As part of their routine clinical care, the participant may be recommended to have an endoscopy, which is a camera test which closely inspects the lining of the stomach.
The doctors would take small samples of tissue from the stomach lining and send them for inspection for signs of pre-cancerous or cancerous changes.
The research team would ask the participants’ permission to collect a small number of extra biopsies which would be analysed by the research team at the University of Cambridge who are investigating how cells develop from normal to cancerous.
The participant would also be asked for provide a blood sample at their first appointment, which would be repeated no more than annually. Alternatively, if they were unable to provide a blood sample, a saliva sample could be sought instead. This blood or saliva sample would help researchers look in more detail for alterations in genes that might be linked to cancer.
Information collected about the participants’ genetic testing and results from their clinical procedures, would be kept on a secure research database maintained by the University of Cambridge. Furthermore, around the time of each endoscopy appointment, the research team would ask the individual to complete a set of mental wellbeing and quality of life questionnaires which will help measure the impact of endoscopic surveillance on their mental wellbeing and quality of life.
As part of the research project, the team would also like to understand more about how diffuse-type gastric cancer develops into an aggressive disease in some individuals. To help investigators do this, they would look at the tumour tissue samples of those who have had gastric cancer. In the cases where the individual has passed away, the research team is asking for the relative's permission to request this tissue sample so that by studying it, research may help those affected by gastric cancer in the future.
‘Section 251 support’ had been provided by the Health Research Authority (HRA), following advice from the Confidentiality Advisory Group (CAG), to allow the research team to process identifiable data regarding the deceased patients.
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Referral information
Clinicians who have identified potentially eligible patients will need to contact the Research Nurse.
If the clinician is ready to send a referral, it should consist of a referral letter, genetic test report and family pedigree.
Individuals may also contact the Research Nurse directly for more information by email.
Please send your questions and/or referrals here