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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-49
SponsorGruppo Oncologico Italiano di Ricerca Clinica

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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 intervention

    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

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: EoGI cancer patients newly diagnosed1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

Secondary Outcome

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

Time frame
Two years
3

Secondary Outcome

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

Time frame
One years from enrollment
4

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

Other outcomes

Sponsors and contacts

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