About this trial
The objective of the study is to create a common and unique platform for the acquisition of biological samples and, subsequently, the possible identification of predictive and prognostic biomarkers for young adults with gastrointestinal and neuroendocrine cancers.The definition "adolescent and young adults (AYA)" covers a broad group of patients ranging from the upper limit of the paediatric competence to the youngest patients usually considered and treated as adults. However, a well-defined and universally accepted age range is still not established. Young adults with cancer have distinct epidemiological, biological, and clinical characteristics, as well as special medical and psychosocial needs that are often unmet. In consideration of their poor representation in clinical studies, as well as the rarer, albeit increasing, frequency at an epidemiological level, knowledge of the risk factors associated with cancers in young adults is very poor. It is therefore of fundamental importance to focus attention on this specific cohort of patients, in order to describe in ever more detail any specific biomolecular aspects, and make full use of the pharmacological resources currently available.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age at diagnosis from18 to 39 years of age
Carcinoma (without limitations for histologic subtypes) from any primary sites: esophagus, stomach, pancreas, biliary tract, liver, small bowel, colon, rectum, anus and cancer of unknown origin
Neuroendocrine neoplasm (NEN) from Gastroenteropancreatic GEP or lung/thymus origin
Tumors at any stage at the first visit
Disqualifiers
Age at diagnosis > 39 years old
Trial population
young adults (18-39 years) with gastrointestinal and neuroendocrine tumors at any stage and any grade with histological diagnosis obtained within two years from the time of enrollment or willingness to undergo bioptic procedure for diagnosis
Trial design
Case-only
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Numbers of partecipants with genetic alterations
Prospective and retrospective observational study to analyze the frequency of tumors in young adults (18-49 years) with gastrointestinal and neuroendocrine tumors. Identification of genetic alterations with correlation between somatic and germline alterations.
Secondary outcomes
Number of partecipants with survival outcomes
Describe survival outcomes (overall survival and progression-free survival) according to the main clinical-pathological features and treatment received.
Number of partecipants toxicities
Describe potential toxicities developed as results of treatments according to clinical-pathological, genomic features and treatment received.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.