En prospektiv observasjonsstudie av tidlig debut gastrointestinal kreft: Fra svulstegenskaper til pasientens livsstilsvaner (YOGICO)
En prospektiv observasjonsstudie av tidlig debut gastrointestinal kreft: Fra svulstegenskaper til pasientens livsstilsvaner - YOGICO-studien
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
Studieoversikt
Status
Detaljert beskrivelse
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).
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Ilaria Bernardini, MD
- Telefonnummer: +39 059659294
- E-post: i.bernardini@ausl.mo.it
Studiesteder
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BO
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Bologna, BO, Italia
- Har ikke rekruttert ennå
- Oncologia, Ospedale Sant'Orsola
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Ta kontakt med:
- Karim Rihawi, MD
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FC
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Meldola, FC, Italia
- Aktiv, ikke rekrutterende
- Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST
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MO
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Carpi, MO, Italia
- Rekruttering
- Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena
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Ta kontakt med:
- Claudia Mucciarini, MD
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Modena, MO, Italia
- Aktiv, ikke rekrutterende
- Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena
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Sassuolo, MO, Italia
- Rekruttering
- Oncologia Area Sud Ausl Modena
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Ta kontakt med:
- Teresa Zielli, MD
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Minnesota
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Mantua, Minnesota, Italia
- Aktiv, ikke rekrutterende
- Oncologia Ospedale Carlo Poma di Mantova
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PC
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Piacenza, PC, Italia
- Aktiv, ikke rekrutterende
- Oncologia Medica, AUSL Piacenza
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PR
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Parma, PR, Italia
- Rekruttering
- Oncologia, Azienda Ospedaliero Universitaria di Parma
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Ta kontakt med:
- Annalisa Gilli, MD
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RE
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Reggio Emilia, RE, Italia
- Rekruttering
- Oncologia Medica, CORE Azienda USL-IRCCS Reggio Emilia
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Ta kontakt med:
- Francesco Caputo, MD
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RN
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Rimini, RN, Italia
- Rekruttering
- Oncologia, Ospedale di Rimini
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Ta kontakt med:
- Francesca Fabbri, MD
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VA
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Varese, VA, Italia
- Har ikke rekruttert ennå
- Oncologia, ASST SETTE LAGHI, Ospedale di Circolo
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Ta kontakt med:
- Michele Ghidini, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
EoGI-kreftpasienter nylig diagnostisert
|
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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary outcome
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Secondary outcome measure
Tidsramme: 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
Tidsramme: Two years
|
Incidence and prevalence of newly diagnosed EoGI cancer at each participating site during the study accrual time period |
Two years
|
|
Secondary Outcome
Tidsramme: One years from enrollment
|
Description of patients' lifetime exposure to behavioral and cancer-related risk factors |
One years from enrollment
|
|
Secondary Outcome
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GOIRC-03-2025
Legemiddel- og utstyrsinformasjon, studiedokumenter
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