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NCT Number: NCT07479472

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

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

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Key information

Conditions

Early-onset Gastrointestinal Cancer

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oncologia, Ospedale Sant'Orsola, Bologna, BO, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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, in a real-world Italian settings, mainly located in Northern Italy

Primary outcomes

  1. Primary outcome

    Time frame: One year from the enrollment

    Describe clinical and tumor features of newly diagnosed EoGI cancer patients in a real-world Italian setting.

Secondary outcomes

  1. Secondary outcome measure

    Time frame: Six and twelve months follow-up

    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.

  2. Secondary Outcome

    Time frame: Two years

    Incidence and prevalence of newly diagnosed EoGI cancer at each participating site during the study accrual time period

  3. Secondary Outcome

    Time frame: One years from enrollment

    Description of patients' lifetime exposure to behavioral and cancer-related risk factors

  4. Secondary Outcome

    Time frame: One years from enrollment

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ilaria Bernardini, MD

CONTACT

[email protected]

+39 059659294

Sponsors and collaborators

Lead sponsor

Gruppo Oncologico Italiano di Ricerca Clinica

Other

Registry information

Official study title

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

Acronym: YOGICO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.