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Not yet recruiting NCT07479472

A Prospective Observational Study on of Early-Onset Gastrointestinal Cancer: From Tumor Features to Patient Lifestyle Habits

Observational Early-onset Gastrointestinal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: to characterize the distinctive features of EO-GI cancer through a comprehensive approach that considers clinical and demographic factors, tumor features, and patient lifestyle habits.
Who it may be relevant to
Registry conditions: Early-onset Gastrointestinal Cancer. Basic parameters: 18 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Observational Study on of Early-Onset Gastrointestinal Cancer: From Tumor Features to Patient Lifestyle Habits - YOGICO Study

Overview

The YOGICO study aims to characterize the distinctive features of EoGI cancer through a holistic approach that integrates clinical and demographic data, tumor biological characteristics, and patient lifestyle habits

Detailed description

This is an observational, prospective multicenter study to characterize newly diagnosed EoGI cancer patients from a holistic approach, covering aspects from tumor features to patient lifestyle habits. Since this is a prospective observational study, participation does not alter any cancer treatments that patients will undergo after their cancer diagnosis, as per best clinical practice at each participating center. The number of patients included in the study will range from 150 to 200, enrolled in national centers located in northern Italy, as well as in diverse hospital settings (e.g., small vs. large hospitals).

Interventions

  • Other to characterize the distinctive features of EO-GI cancer through a comprehensive approach that considers clinical and demographic factors, tumor features, and patient lifestyle habits
    to characterize the distinctive features of EO-GI cancer through a comprehensive approach that considers clinical and demographic factors, tumor features, and patient lifestyle habits, in a real-world Italian settings, mainly located in Northern Italy

Primary outcome measures

  • Primary outcome [Time frame: One year from the enrollment]
Secondary outcome measures (4)
  • Secondary outcome measure [Time frame: Six and twelve months follow-up]
  • Secondary Outcome [Time frame: Two years]
  • Secondary Outcome [Time frame: One years from enrollment]
  • Secondary Outcome [Time frame: One years from enrollment]

Eligibility criteria

Inclusion criteria

  • Provide a signed and dated informed consent form (ICF)
  • Willing to comply with all study procedures and be available for the duration of the study
  • Male or female, aged 18-49 years old at time of EoGI cancer diagnosis
  • Patients with newly diagnosed early-onset gastrointestinal cancer histologically confirmed: colorectal, gastroesophageal and pancreatic tumor site, regardless of histological type
  • Any disease stage, performance status, and type of treatment, including experimental therapies and supportive care
  • Previous or concomitant malignancies are allowed provided they do not involve the gastrointestinal tract

Exclusion criteria

  • Cognitive, linguistic, or physical barriers that prevent a detailed reconstruction of the patient's personal medical history including past lifestyle habits
  • Having previously received any treatments directed at the newly diagnosed EOGI cancer (i.e., at the time of inclusion, the patient has not yet started any type of treatment, excluding surgery)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 11 centers
  • Oncologia, Ospedale Sant'Orsola — Bologna
  • Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST — Meldola
  • Oncologia Ospedale Carlo Poma di Mantova — Mantua
  • Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena — Carpi
  • Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena — Modena
  • Oncologia Area Sud Ausl Modena — Sassuolo
  • Oncologia Medica, AUSL Piacenza — Piacenza
  • Oncologia, Azienda Ospedaliero Universitaria di Parma — Parma
  • … and 3 more centers

Identifiers

NCT: NCT07479472 · GOIRC-03-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗