ClinicalTrials.gg
RecruitingNCT07479472YOGICOUpdated Oct 6, 2026

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

An observational study in Early-onset Gastrointestinal Cancer, sponsored by Gruppo Oncologico Italiano di Ricerca Clinica. Recruiting at 11 sites in Italy. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Gruppo Oncologico Italiano di Ricerca Clinica · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Oct 6, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 49 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Early-onset Gastrointestinal Cancer
03

In context

Lead sponsor

Gruppo Oncologico Italiano di Ricerca Clinica is the lead sponsor of 28 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provide a signed and dated 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 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 are allowed provided they do not involve the gastrointestinal tract

Exclusion criteria

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)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

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

    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

06

What researchers measure

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

07

Study locations

5 of 11 sites recruiting
  • Oncologia, Ospedale Sant'Orsola
    Bologna, BO, Italy
    Not yet recruiting
    • Karim Rihawi, MD · Contact
  • Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST
    Meldola, FC, Italy
    Active, not recruiting

    Not enrolling at this site.

  • Oncologia Ospedale Carlo Poma di Mantova
    Mantua, Minnesota, Italy
    Active, not recruiting

    Not enrolling at this site.

  • Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena
    Carpi, MO, Italy
    Recruiting
    • Claudia Mucciarini, MD · Contact
  • Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena
    Modena, MO, Italy
    Active, not recruiting

    Not enrolling at this site.

  • Oncologia Area Sud Ausl Modena
    Sassuolo, MO, Italy
    Recruiting
    • Teresa Zielli, MD · Contact
  • Oncologia Medica, AUSL Piacenza
    Piacenza, PC, Italy
    Active, not recruiting

    Not enrolling at this site.

  • Oncologia, Azienda Ospedaliero Universitaria di Parma
    Parma, PR, Italy
    Recruiting
    • Annalisa Gilli, MD · Contact
  • Oncologia Medica, CORE Azienda USL-IRCCS Reggio Emilia
    Reggio Emilia, RE, Italy
    Recruiting
    • Francesco Caputo, MD · Contact
  • Oncologia, Ospedale di Rimini
    Rimini, RN, Italy
    Recruiting
    • Francesca Fabbri, MD · Contact
  • Oncologia, ASST SETTE LAGHI, Ospedale di Circolo
    Varese, VA, Italy
    Not yet recruiting
    • Michele Ghidini, MD · Contact
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Jul 2026 (actual). Primary completion is estimated for Apr 2028, 21 months after the start.

Start moved once since we started tracking on Sep 25, 2026: Apr 2026 → Jul 2026, on Oct 6, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2026
First posted
Mar 18, 2026
StartActual
Jul 30, 2026was Apr 2026
Primary completionEst.
Apr 2028
CompletionEst.
Apr 2028
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 6, 2026
Sites
1 site added, 1 site removed. 10 sites changed recruiting status (5 now recruiting, 3 now active, not recruiting, …)
Show 10 sites
  • Oncologia, Ospedale Sant'Orsola · Bologna, Italyno status→Not yet recruiting
  • Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST · Meldola, Italyno status→Active, not recruiting
  • Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena · Carpi, Italyno status→Recruiting
  • Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena · Modena, Italyno status→Active, not recruiting
  • Oncologia Area Sud Ausl Modena · Sassuolo, Italyno status→Recruiting
  • Oncologia Medica, AUSL Piacenza · Piacenza, Italyno status→Active, not recruiting
  • Oncologia, Azienda Ospedaliero Universitaria di Parma · Parma, Italyno status→Recruiting
  • Oncologia Medica, CORE Azienda USL-IRCCS Reggio Emilia · Reggio Emilia, Italyno status→Recruiting
  • Oncologia, Ospedale di Rimini · Rimini, Italyno status→Recruiting
  • Oncologia, ASST SETTE LAGHI, Ospedale di Circolo · Varese, Italyno status→Not yet recruiting
Show site
  • Oncologia Ospedale Carlo Poma di Mantova · Mantua, Italy
Show 1 removed
  • Oncologia Ospedale Carlo Poma di Mantova · Mantua, Italy
Oct 6, 2026
Start date
Apr 2026→Jul 30, 2026 (actual)
Oct 6, 2026
Site contacts
Changed at 3 sites. See the sites
Show 3 sites
  • Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST · Meldola, ItalyContact removed (no phone or email listed)
  • Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena · Modena, ItalyContact removed (no phone or email listed)
  • Oncologia Medica, AUSL Piacenza · Piacenza, ItalyContact removed (no phone or email listed)
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Not yet recruiting→Recruiting
    1 site added, 1 site removed. 10 sites changed recruiting status (5 now recruiting, 3 now active, not recruiting, …)
    Show 10 sites
    • Oncologia, Ospedale Sant'Orsola · Bologna, Italyno status→Not yet recruiting
    • Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST · Meldola, Italyno status→Active, not recruiting
    • Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena · Carpi, Italyno status→Recruiting
    • Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena · Modena, Italyno status→Active, not recruiting
    • Oncologia Area Sud Ausl Modena · Sassuolo, Italyno status→Recruiting
    • Oncologia Medica, AUSL Piacenza · Piacenza, Italyno status→Active, not recruiting
    • Oncologia, Azienda Ospedaliero Universitaria di Parma · Parma, Italyno status→Recruiting
    • Oncologia Medica, CORE Azienda USL-IRCCS Reggio Emilia · Reggio Emilia, Italyno status→Recruiting
    • Oncologia, Ospedale di Rimini · Rimini, Italyno status→Recruiting
    • Oncologia, ASST SETTE LAGHI, Ospedale di Circolo · Varese, Italyno status→Not yet recruiting
    Show site
    • Oncologia Ospedale Carlo Poma di Mantova · Mantua, Italy
    Show 1 removed
    • Oncologia Ospedale Carlo Poma di Mantova · Mantua, Italy
    Start date Apr 2026→Jul 30, 2026 (now actual)
    Site contacts Changed at 3 sites. See the sites
    Show 3 sites
    • Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST · Meldola, ItalyContact removed (no phone or email listed)
    • Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena · Modena, ItalyContact removed (no phone or email listed)
    • Oncologia Medica, AUSL Piacenza · Piacenza, ItalyContact removed (no phone or email listed)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07479472
Lead sponsor
Gruppo Oncologico Italiano di Ricerca Clinica
Responsible party
Sponsor
First posted
Mar 18, 2026
Start date
Jul 30, 2026
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Oct 6, 2026

Study contacts

Ilaria Bernardini, MD
Contact
i.bernardini@ausl.mo.it
+39 059659294

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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