Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337760
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-18
Brief Title:
YOUNg Adults With Gastro-inteSTinal GI and nEuroendocrine canceRs
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
YOUNg Adults With Gastro-inteSTinal GI and nEuroendocrine canceRs YOUNGSTER
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YOUNGSTER
Brief 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 cancersThe 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
Detailed 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 US 89500 new cases and 9270 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 httpswwwaiomitwpcontentuploads2020102020_Numeri_Cancro-operatori-webpdf 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 biomarkersThis 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
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 biomarkersThis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None