Étude observationnelle prospective sur le cancer gastro-intestinal à début précoce : des caractéristiques tumorales aux habitudes de vie des patients (YOGICO)
Une étude observationnelle prospective sur le cancer gastro-intestinal à début précoce : des caractéristiques tumorales aux habitudes de vie des patients - Étude YOGICO
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ilaria Bernardini, MD
- Numéro de téléphone: +39 059659294
- E-mail: i.bernardini@ausl.mo.it
Lieux d'étude
-
-
BO
-
Bologna, BO, Italie
- Pas encore de recrutement
- Oncologia, Ospedale Sant'Orsola
-
Contact:
- Karim Rihawi, MD
-
-
FC
-
Meldola, FC, Italie
- Actif, ne recrute pas
- Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST
-
-
MO
-
Carpi, MO, Italie
- Recrutement
- Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena
-
Contact:
- Claudia Mucciarini, MD
-
Modena, MO, Italie
- Actif, ne recrute pas
- Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena
-
Sassuolo, MO, Italie
- Recrutement
- Oncologia Area Sud Ausl Modena
-
Contact:
- Teresa Zielli, MD
-
-
Minnesota
-
Mantua, Minnesota, Italie
- Actif, ne recrute pas
- Oncologia Ospedale Carlo Poma di Mantova
-
-
PC
-
Piacenza, PC, Italie
- Actif, ne recrute pas
- Oncologia Medica, AUSL Piacenza
-
-
PR
-
Parma, PR, Italie
- Recrutement
- Oncologia, Azienda Ospedaliero Universitaria di Parma
-
Contact:
- Annalisa Gilli, MD
-
-
RE
-
Reggio Emilia, RE, Italie
- Recrutement
- Oncologia Medica, CORE Azienda USL-IRCCS Reggio Emilia
-
Contact:
- Francesco Caputo, MD
-
-
RN
-
Rimini, RN, Italie
- Recrutement
- Oncologia, Ospedale di Rimini
-
Contact:
- Francesca Fabbri, MD
-
-
VA
-
Varese, VA, Italie
- Pas encore de recrutement
- Oncologia, ASST SETTE LAGHI, Ospedale di Circolo
-
Contact:
- Michele Ghidini, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Patients atteints d'un cancer EoGI nouvellement diagnostiqués
|
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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Primary outcome
Délai: One year from the enrollment
|
Describe clinical and tumor features of newly diagnosed EoGI cancer patients in a real-world Italian setting. |
One year from the enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Secondary outcome measure
Délai: Six and twelve months follow-up
|
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. |
Six and twelve months follow-up
|
|
Secondary Outcome
Délai: Two years
|
Incidence and prevalence of newly diagnosed EoGI cancer at each participating site during the study accrual time period |
Two years
|
|
Secondary Outcome
Délai: One years from enrollment
|
Description of patients' lifetime exposure to behavioral and cancer-related risk factors |
One years from enrollment
|
|
Secondary Outcome
Délai: One years from enrollment
|
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 |
One years from enrollment
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GOIRC-03-2025
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .