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

N/ANot Yet RecruitingNCT07479472

Gruppo Oncologico Italiano di Ricerca Clinica150 enrolled

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

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

150

Conditions

Early-onset Gastrointestinal Cancer

Interventions

to characterize the distinctive features of EO-GI cancer through a comprehensive approach that considers clinical and demographic factors, tumor features, and patient lifestyle habitsOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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)

Locations (11)

Oncologia, Ospedale Sant'Orsola

Bologna, BO, Italy

Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST

Meldola, FC, Italy

Oncologia Ospedale Carlo Poma di Mantova

Mantua, MN, Italy

Outcomes

Primary Outcomes

Primary outcome

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

Time frame: One year from the enrollment

Secondary Outcomes

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.

Time frame: 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

Time frame: Two years

Secondary Outcome

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

Time frame: 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

Time frame: One years from enrollment

Central Contacts

Ilaria Bernardini, MD

CONTACT

+39 059659294 i.bernardini@ausl.mo.it

Data from ClinicalTrials.gov

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