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Идёт набор NCT06326879

A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients

— Наблюдательное Colorectal 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: No intervention.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer. Базовые параметры: от 18 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

Early-Onset Colorectal Cancer Versus Late-Onset Colorectal Cancer: a Prospective Observational Cohort Study to Explore the Clinical, Sociodemographic, Genetic, and Molecular Characteristics Associated With Adverse Oncological Outcomes (

Обзор

This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients

Подробное описание

Early Onset Colorectal Cancer (EOCRC), defined as a Colorectal Cancer (CRC) arising before the age of 50, is increasing and displays more aggressive features compared with Late Onset Colorectal Cancer (LOCRC, with a diagnosis after the age of 50). EOCRC patients have indeed a higher incidence rate of CRC recurrence after surgery compared with LOCRC, even at early CRC stages (stage I or II). The reasons underlying the more aggressive patterns are almost unknown but may span and can be represented by a combination of socioeconomic factors (including low economic income and access to screening programs, diagnosis, or therapy), behavioral and lifestyle factors (including diet, sedentary behaviors, or increased stress and anxiety), and molecular or genetic factors.

The aim of this study is to prospectively validate our previous retrospective findings, demonstrating a higher incidence rate of CRC recurrence in early stage EOCRC, and explore the possible association between lifestyle, dietary, socioeconomics, molecular and genetic factors and postoperative CRC survival.

Вмешательства

  • Другое No intervention
    Questionnaires compilation and sample collection

Первичные конечные точки

  • Incidence rate ratio of colorectal cancer recurrence [Срок оценки: 24 months after surgery]
Вторичные конечные точки (4)
  • Correlation between lifestyle and incidence rate of colorectal cancer recurrence [Срок оценки: 24 months after surgery]
  • Correlation between genetic profile and incidence rate of colorectal cancer recurrence [Срок оценки: 24 months after surgery]
  • Correlation between molecular profile and incidence rate of colorectal cancer recurrence [Срок оценки: 24 months after surgery]
  • Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence [Срок оценки: 24 months after surgery]

Критерии участия

Критерии включения

  • Patients aged more than 18 years old at the time of inclusion.
  • Patients with a proven diagnosis of colorectal adenocarcinoma, as reported by the staging histological biopsies.
  • Patients with a preoperative staging I-III.
  • Patients scheduled for elective curative colorectal resection.
  • Patients with rectal cancer who underwent neoadjuvant therapy can be included in the study.
  • Patients able and willing to comply with the protocol requirements (samples' collection and questionnaires' compilation).

Критерии исключения

  • Patients with metastatic disease at diagnosis.
  • Patients requiring an emergent procedure.
  • Patients undergoing palliative surgery (for example, fecal diversion).
  • Patients with a surgical indication for benign lesions (for example, adenoma or dysplasia).
  • Patients with an intraoperative finding of a lesion other than adenocarcinoma will be withdrawn from the study.
  • Patients with an intraoperative finding of distal metastasis or peritoneal carcinosis will be withdrawn from the study.
  • Patients with a concomitant diagnosis of Inflammatory Bowel Disease.
  • Patients with a known genetic syndrome (for example, Lynch syndrome or Familial Adenomatous Polyposis).

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 · 1 центр
  • IRCCS Humanitas Research Hospital — Rozzano

Идентификаторы

NCT: NCT06326879 · 3527

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗