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Neuroendocrine NeoplasmYOUNGSTERNCT06337760

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

An observational study of Neuroendocrine Neoplasm and Adenocarcinoma, run by European Institute of Oncology at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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)"… Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Neuroendocrine Neoplasm, Adenocarcinoma
How many people
90 participants
Where
1 siteItaly
Study dates
10 Mar 2023to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • Adult

Study 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

Who may be able to join

  • 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
  • Tumors of any grade
  • Histological diagnosis obtained within two years from the time of enrollment or willingness to undergo bioptic procedure for diagnosis

Who cannot join

  • Age at diagnosis > 39 years old

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cristina Mazzon contact

cristina.mazzon@ieo.it

Italy1 site, 1 recruiting
  • European Institute of Oncology

    Milan

    Lorenzo Gervaso, MD

    Chiara Alessandra Cella, MD

    Recruiting

Other trials in Italy

About this study

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.

Read the 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 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.

Keywords
young adult, Gastro-intestinal cancer, Neuroendocrine cancer, molecular analysis, prognostic biomarker
Medical subject headings
Neuroendocrine Tumors, Adenocarcinoma, Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06337760
Study groupRoleWhat they receive
neuroendocrine neoplasm young patientPatients aged at diagnosis from18 to 39 years of age with neuroendocrine neoplasm NEN from Gastroenteropancreatic (GEP) or lung/thymus origin
adenocarcinoma young patientPatients aged at diagnosis from18 to 39 years of age with 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3,5 years

Secondary outcomes (2)
  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.

    Measured: 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.

    Measured: 3,5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2024
  2. Study start10 Mar 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06337760
Sponsor's protocol ID
IEO 1669
Acronym
YOUNGSTER
Status last verified
Mar 2024
First submitted
18 Mar 2024
Last updated
29 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neuroendocrine Neoplasm and Adenocarcinoma, run by European Institute of Oncology at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lorenzo Gervaso, MD (+390257489258, divisione.gastrointestinale@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numbers of partecipants with genetic alterations (time frame: 3,5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.

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