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

NCT06337760 | Recruiting

• 1 other identifier: IEO 1669
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neuroendocrine Neoplasm; Adenocarcinoma

Keywords

young adult; Gastro-intestinal cancer; Neuroendocrine cancer; molecular analysis; prognostic biomarker

Outcome Measures

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.

  3,5 years

Secondary Outcomes (2)

• Number of partecipants with survival outcomes

  3,5 years

• Number of partecipants toxicities

  3,5 years

Study Arms (2)

neuroendocrine neoplasm young patient

Patients aged at diagnosis from18 to 39 years of age with neuroendocrine neoplasm NEN from Gastroenteropancreatic (GEP) or lung/thymus origin

adenocarcinoma young patient

Patients 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.

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Age at diagnosis \> 39 years old

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor sample blood sample (optional)

MeSH Terms

Conditions

Neuroendocrine Tumors; Adenocarcinoma; Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Carcinoma; Neoplasms, Glandular and Epithelial

Study Officials

• Francesca Spada, MD

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Gervaso, MD

CONTACT

+390257489258; divisione.gastrointestinale@ieo.it

Cristina Mazzon

CONTACT

cristina.mazzon@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 29, 2024
• Study Start: March 10, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)