Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06337760 |
| Other study ID # |
IEO 1669 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2023 |
| Est. completion date |
June 30, 2027 |
Study information
| Verified date |
March 2024 |
| Source |
European Institute of Oncology |
| Contact |
Lorenzo Gervaso, MD |
| Phone |
+390257489258 |
| Email |
divisione.gastrointestinale[@]ieo.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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. In fact, AYA includes patients from 16 to 24 years old according to the
Britannic association "Teenage Cancer Trust" or 39 years old for the American National Cancer
Institute definitions, respectively. Over the past 30 years, the incidence of cancer in AYA
patients has increased globally by approximately 30%, estimating, in 2020 in U.S, 89,500 new
cases and 9,270 deaths due to cancer among AYAs. Although the most frequent tumors are germ
cell cancer for males and breast and thyroid cancers for female across the world, and
confirmed also in Italian registries
(https://www.aiom.it/wpcontent/uploads/2020/10/2020_Numeri_Cancro-operatori-web.pdf),
malignancies arising from the gastrointestinal tract account all together for around 10% of
cases. These are mainly represented by gastric cancer (up to 5%) followed by colorectal,
neuroendocrine and hepatobiliary tumors.
Due to the high impact in terms of social impairment, a new and specific classification
system based on the International Classification of Diseases for Oncology (ICD-O) and the
World Health Organization (WHO) Classification of Tumors series for AYA cancers has been
recently presented in order to sharpen the medical needs of this population.
However, AYA cohort remains a major clinical challenge, especially because of its poor
representation in clinical trials, which prevent from the possibility to create a profile
with specific molecular and etiopathogenetic features. Even though a significant part of
these tumors rises from a hereditary basis (often in patients already followed by medical
Genetic Unit), in most cases, cancers are sporadic, only partially associated to earlier
exposure to carcinogenic factors such as alcohol and smoking, as well as a sedentary
lifestyle and poor dietary education. Therefore, many questions remain unsolved regarding
carcinogenesis, treatment, prognosis, and, eventually, prevention for family members of these
patients.
Moreover, AYAs have a higher risk - even if lower than pediatric patients - to present
long-term and late-onset side effects, concerning infertility, sexual disfunction,
cardiotoxicity and second tumors. Early predictors biomarkers of these potential consequences
are strongly needed. Considering current scarce information regarding how to improve outcomes
of young patients affected by GI cancers and neuroendocrine neoplasms, this study aims to
shed light on the biological behavior and the unmet needs of this population, by correlating
clinical and biological factors to clinical outcomes. The main goal will be, firstly, the
creation of a common and unique platform for acquiring biological samples and subsequently,
potentially the identification of predictive and prognostic biomarkers.This study comprises
both a retrospective and prospective phase. For the retrospective one, AYA patients will be
included with GI or NeuroEndocrine (NE) malignancies (histologically confirmed). In the
prospective part, when the study will be actively recruiting, clinical and biological data of
all AYA patients will be collected and analyzed, according to specific outcomes.
