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Набор скоро начнётся NCT07479472

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

— Наблюдательное Early-onset Gastrointestinal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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.
Кому может быть актуально
Состояния в реестре: Early-onset Gastrointestinal Cancer. Базовые параметры: 18 лет — 49 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

  • Другое 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
    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

Первичные конечные точки

  • Primary outcome [Срок оценки: One year from the enrollment]
Вторичные конечные точки (4)
  • Secondary outcome measure [Срок оценки: Six and twelve months follow-up]
  • Secondary Outcome [Срок оценки: Two years]
  • Secondary Outcome [Срок оценки: One years from enrollment]
  • Secondary Outcome [Срок оценки: One years from enrollment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 11 центров
  • Oncologia, Ospedale Sant'Orsola — Bologna
  • Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST — Meldola
  • Oncologia Ospedale Carlo Poma di Mantova — Mantua
  • Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena — Carpi
  • Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena — Modena
  • Oncologia Area Sud Ausl Modena — Sassuolo
  • Oncologia Medica, AUSL Piacenza — Piacenza
  • Oncologia, Azienda Ospedaliero Universitaria di Parma — Parma
  • … и ещё 3 центра

Идентификаторы

NCT: NCT07479472 · GOIRC-03-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗