Estudio Observacional Prospectivo sobre el Cáncer Gastrointestinal de Inicio Temprano: Desde las Características del Tumor hasta los Hábitos de Estilo de Vida del Paciente (YOGICO)
Estudio Prospectivo Observacional sobre el Cáncer Gastrointestinal de Inicio Temprano: Desde las Características del Tumor hasta los Hábitos de Estilo de Vida del Paciente - Estudio 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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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).
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ilaria Bernardini, MD
- Número de teléfono: +39 059659294
- Correo electrónico: i.bernardini@ausl.mo.it
Ubicaciones de estudio
-
-
BO
-
Bologna, BO, Italia
- Aún no reclutando
- Oncologia, Ospedale Sant'Orsola
-
Contacto:
- Karim Rihawi, MD
-
-
FC
-
Meldola, FC, Italia
- Activo, no reclutando
- Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST
-
-
MO
-
Carpi, MO, Italia
- Reclutamiento
- Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena
-
Contacto:
- Claudia Mucciarini, MD
-
Modena, MO, Italia
- Activo, no reclutando
- Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena
-
Sassuolo, MO, Italia
- Reclutamiento
- Oncologia Area Sud Ausl Modena
-
Contacto:
- Teresa Zielli, MD
-
-
Minnesota
-
Mantua, Minnesota, Italia
- Activo, no reclutando
- Oncologia Ospedale Carlo Poma di Mantova
-
-
PC
-
Piacenza, PC, Italia
- Activo, no reclutando
- Oncologia Medica, AUSL Piacenza
-
-
PR
-
Parma, PR, Italia
- Reclutamiento
- Oncologia, Azienda Ospedaliero Universitaria di Parma
-
Contacto:
- Annalisa Gilli, MD
-
-
RE
-
Reggio Emilia, RE, Italia
- Reclutamiento
- Oncologia Medica, CORE Azienda USL-IRCCS Reggio Emilia
-
Contacto:
- Francesco Caputo, MD
-
-
RN
-
Rimini, RN, Italia
- Reclutamiento
- Oncologia, Ospedale di Rimini
-
Contacto:
- Francesca Fabbri, MD
-
-
VA
-
Varese, VA, Italia
- Aún no reclutando
- Oncologia, ASST SETTE LAGHI, Ospedale di Circolo
-
Contacto:
- Michele Ghidini, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Pacientes con cáncer de EoGI recién diagnosticados
|
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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Primary outcome
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Secondary outcome measure
Periodo de tiempo: 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
Periodo de tiempo: Two years
|
Incidence and prevalence of newly diagnosed EoGI cancer at each participating site during the study accrual time period |
Two years
|
|
Secondary Outcome
Periodo de tiempo: One years from enrollment
|
Description of patients' lifetime exposure to behavioral and cancer-related risk factors |
One years from enrollment
|
|
Secondary Outcome
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GOIRC-03-2025
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .