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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Early-onset Gastrointestinal Cancer
• Intervention / Treatment: 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

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).

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Ilaria Bernardini, MD; Phone Number: +39 059659294; Email: i.bernardini@ausl.mo.it

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy
      • Oncologia, Ospedale Sant'Orsola
      • Contact: Karim Rihawi, MD
  • FC
    • Meldola, FC, Italy
      • Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST
      • Contact: Ilario Rasparelli, MD
  • MN
    • Mantova, MN, Italy
      • Oncologia Ospedale Carlo Poma di Mantova
      • Contact: Francesca Turina, MD
  • MO
    • Carpi, MO, Italy
      • Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena
      • Contact: Claudia Mucciarini, MD
    • Modena, MO, Italy
      • Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena
      • Contact: Alessandro Spallanzani, MD
    • Sassuolo, MO, Italy
      • Oncologia Area Sud Ausl Modena
      • Contact: Teresa Zielli, MD
  • PC
    • Piacenza, PC, Italy
      • Oncologia Medica, AUSL Piacenza
      • Contact: Margherita Ratti, MD
  • PR
    • Parma, PR, Italy
      • Oncologia, Azienda Ospedaliero Universitaria di Parma
      • Contact: Annalisa Gilli, MD
  • RE
    • Reggio Emilia, RE, Italy
      • Oncologia Medica, CORE Azienda USL-IRCCS Reggio Emilia
      • Contact: Francesco Caputo, MD
  • RN
    • Rimini, RN, Italy
      • Oncologia, Ospedale di Rimini
      • Contact: Francesca Fabbri, MD
  • VA
    • Varese, VA, Italy
      • Oncologia, ASST SETTE LAGHI, Ospedale di Circolo
      • Contact: Michele Ghidini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected and recruited during routine medical appointments by specialized medical oncologists at the participating cancer center. Patients will be enrolled consecutively based on inclusion and exclusion criteria

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

EoGI cancer patients newly diagnosed

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	Describe clinical and tumor features of newly diagnosed EoGI cancer patients in a real-world Italian setting.	One year from the enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome measure	EoGI cancer type of treatment at diagnosis (chemotherapy, immunotherapy, targeted therapy, surgery, radiotherapy or best supportive care); progression of disease (if any) and survival status at 6 and 12 months follow-up.	Six and twelve months follow-up
Secondary Outcome	Incidence and prevalence of newly diagnosed EoGI cancer at each participating site during the study accrual time period	Two years
Secondary Outcome	Description of patients' lifetime exposure to behavioral and cancer-related risk factors	One years from enrollment
Secondary Outcome	Identify associations between past lifestyle habits (diet, physical activity, smoking, alcohol consumption,) and tumor-related features (stage, histology, anatomical site, and molecular markers) in EoGI cancer patients	One years from enrollment

Collaborators and Investigators

• Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Public Health; Environment and Public Health; Population Characteristics; Epidemiologic Measurements; Demography
• Other Study ID Numbers: GOIRC-03-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No