Adenocarcinoma Clinical Trial
Official title:
YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs (YOUNGSTER).
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05678218 -
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
|
||
Recruiting |
NCT05161572 -
Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
Withdrawn |
NCT05325164 -
Methadone for 'Adenocarcinopathic' Pain Treatment
|
Phase 3 | |
Completed |
NCT02926768 -
Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT02125240 -
Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
|
Phase 3 | |
Completed |
NCT02374411 -
Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
|
N/A | |
Completed |
NCT02454647 -
Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients
|
N/A | |
Completed |
NCT01579721 -
Prospective Randomized Study of SILS Versus CLS for Rectal Cancer
|
Phase 4 | |
Withdrawn |
NCT01148082 -
School Response to Families Who Have Children With Cancer
|
N/A | |
Completed |
NCT01206530 -
FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00548548 -
A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
|
Phase 3 | |
Completed |
NCT00377936 -
EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
|
Phase 2 | |
Completed |
NCT00129844 -
Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00183859 -
Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan
|
Phase 1 | |
Recruiting |
NCT01930864 -
Metformin Plus Irinotecan for Refractory Colorectal Cancer
|
Phase 2 | |
Completed |
NCT02498860 -
Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung
|
Phase 2 | |
Terminated |
NCT01441128 -
-02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer
|
Phase 1 | |
Active, not recruiting |
NCT04400474 -
Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study
|
Phase 2 | |
Recruiting |
NCT02133196 -
T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
|
Phase 2 |