Early-onset Gastrointestinal CancerYOGICONCT07479472
A Prospective Observational Study on of Early-Onset Gastrointestinal Cancer: From Tumor Features to Patient Lifestyle Habits
An observational study of Early-onset Gastrointestinal Cancer, run by Gruppo Oncologico Italiano di Ricerca Clinica at 11 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Early-onset Gastrointestinal Cancer
- What is being tested?
- 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
- How many people
- 150 participants
- Where
- 11 sitesItaly
- Study dates
- 30 Jul 2026to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Italy11 sites, 7 recruiting
- Not yet recruiting
Oncologia, Ospedale Sant'Orsola
Bologna, BO
Karim Rihawi, MD
- Recruiting
Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena
Carpi, MO
Claudia Mucciarini, MD
- Active, not recruiting
Oncologia Ospedale Carlo Poma di Mantova
Mantua, Minnesota
- Active, not recruiting
Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST
Meldola, FC
- Active, not recruiting
Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena
Modena, MO
- Recruiting
Oncologia, Azienda Ospedaliero Universitaria di Parma
Parma, PR
Annalisa Gilli, MD
- Active, not recruiting
Oncologia Medica, AUSL Piacenza
Piacenza, PC
- Recruiting
Oncologia Medica, CORE Azienda USL-IRCCS Reggio Emilia
Reggio Emilia, RE
Francesco Caputo, MD
- Recruiting
Oncologia, Ospedale di Rimini
Rimini, RN
Francesca Fabbri, MD
- Recruiting
Oncologia Area Sud Ausl Modena
Sassuolo, MO
Teresa Zielli, MD
- Not yet recruiting
Oncologia, ASST SETTE LAGHI, Ospedale di Circolo
Varese, VA
Michele Ghidini, MD
About this study
Official title: 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
Read the 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).
- Conditions
- Early-onset Gastrointestinal Cancer
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| EoGI cancer patients newly diagnosed | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Describe clinical and tumor features of newly diagnosed EoGI cancer patients in a real-world Italian setting.
Measured: One year from the enrollment
Secondary outcomes (4)
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.
Measured: 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
Measured: Two years
Secondary Outcome
Description of patients' lifetime exposure to behavioral and cancer-related risk factors
Measured: 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
Measured: One years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start30 Jul 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-onset Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479472
- Sponsor's protocol ID
- GOIRC-03-2025
- Acronym
- YOGICO
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on of Early-Onset Gastrointestinal Cancer: From Tumor Features to Patient Lifestyle Habits - YOGICO Study
- ClinicalTrials.gov ID
- NCT07479472
- Acronym / sponsor ID
- YOGICO / GOIRC-03-2025
- Conditions
- Early-onset Gastrointestinal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca ClinicaUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| to characterize the distinctive features of EO-GI cancer through a comprehensive approach that considers clinical and demographic factors, tumor features, and patient lifestyle habitsto 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 | Other | EoGI cancer patients newly diagnosed |
Primary outcome
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.
4 secondary outcomes
Secondary outcome measure
Time frame: Six and twelve months follow-up
Secondary Outcome
Time frame: Two years
Secondary Outcome
Time frame: One years from enrollment
Secondary Outcome
Time frame: One years from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early-onset Gastrointestinal Cancer, run by Gruppo Oncologico Italiano di Ricerca Clinica at 11 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Bernardini, MD (+39 059659294, i.bernardini@ausl.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: One year from the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.