YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-39
SponsorEuropean Institute of Oncology

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 2 trial groups
Group A: neuroendocrine neoplasm young patient
Group B: adenocarcinoma young patient

Trial outcomes

Primary outcomes

1

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.

Time frame
3,5 years

Secondary outcomes

1

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.

Time frame
3,5 years
2

Number of partecipants toxicities

Describe potential toxicities developed as results of treatments according to clinical-pathological, genomic features and treatment received.

Time frame
3,5 years

Other outcomes

Sponsors and contacts

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