A Prospective Observational Study on of Early-Onset Gastrointestinal Cancer: From Tumor Features to Patient Lifestyle Habits - YOGICO Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 11
- Primary Endpoint
- Primary outcome
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
EoGI cancer patients newly diagnosed
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 (Other)
Outcomes
Primary Outcomes
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
- Secondary outcome measure(Six and twelve months follow-up)
- Secondary Outcome(Two years)
- Secondary Outcome(One years from enrollment)