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Идёт набор NCT07747688

Retrospective Analysis of Early Gastric Cancer Patients Based on Prospective Clinical Dataset

— Наблюдательное Early Gastric 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: Clinical Data Collection.
Кому может быть актуально
Состояния в реестре: Early Gastric Cancer. Базовые параметры: 18 лет — 90 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
Китай
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

Establishing an Innovative Cohort for Chinese Early Gastric Cancer Patients Based on the National Clinical Research Center for Digestive Diseases Prospective Database: A Retrospective Study

Обзор

The goal of this retrospective observational cohort study is to describe the real-world clinicopathological characteristics, evolving treatment patterns, and long-term oncological outcomes of early gastric cancer (EGC) patients in China, utilizing a large prospective clinical database. The main questions it aims to answer are: How do different treatment modalities, including endoscopic resection, laparoscopic surgery, open surgery, and combined laparoscopic-endoscopic approaches, influence the long-term survival (Overall Survival and Disease-Free Survival) and recurrence patterns in Chinese EGC patients? What are the key clinicopathological factors affecting prognosis in this population? This study will retrospectively enroll approximately 5000 patients with histopathologically confirmed gastric adenocarcinoma staged as early gastric cancer (per AJCC 8th edition) from the information database of the National Clinical Research Center for Digestive Diseases. Researchers will systematically collect baseline demographics, treatment details, surgical complications, pathological staging, and longitudinal follow-up data (up to 10 years post-surgery) for all eligible patients. By comparing the short-term safety profiles and long-term survival benefits across different treatment groups and identifying risk factors for recurrence, this study aims to provide high-quality, China-specific evidence to guide standardized and individualized clinical decision-making for early gastric cancer.

Вмешательства

  • Другое Clinical Data Collection
    Retrospective collection of clinicopathological characteristics, treatment details, and long-term follow-up data from electronic medical records and the institutional database.

Первичные конечные точки

  • Disease-Free Survival [Срок оценки: From date of surgery to up to 10 years post-surgery]
Вторичные конечные точки (12)
  • Overall Survival [Срок оценки: From date of surgery to up to 10 years post-surgery]
  • Recurrence-Free Survival [Срок оценки: From the date of surgery to 10 years post-surgery]
  • Progression-Free Survival [Срок оценки: From the date of surgery to 10 years post-surgery]
  • 30-Day Postoperative Complications [Срок оценки: From the date of surgery to 30 days post-surgery]
  • 30-Day Postoperative Mortality [Срок оценки: From the date of surgery to 30 days post-surgery]
  • Unscheduled Second Surgery Rate [Срок оценки: From the date of surgery to 30 days post-surgery]
  • Unplanned Return to Hospital Rate [Срок оценки: From the date of surgery to 30 days post-surgery]
  • Operation Time [Срок оценки: At the time of surgery]
  • Intraoperative Blood Loss [Срок оценки: At the time of surgery]
  • Postoperative Length of Stay [Срок оценки: From date of surgery until date of hospital discharge, assessed up to 2 weeks]
  • Preoperative Endoscopic Tumor Size [Срок оценки: From 30 days prior to surgery to the date of surgery]
  • Preoperative Endoscopic Macroscopic Type [Срок оценки: From 30 days prior to surgery to the date of surgery]

Критерии участия

Критерии включения

  • patients aged between 18 and 90 years;
  • preoperative endoscopic biopsy-confirmed gastric adenocarcinoma;
  • clinical stage early gastric (cT1NxM0) cancer according to the AJCC 8th edition TNM staging system;
  • patients who have signed a broad informed consent.
  • Received primary treatment (including endoscopic resection, laparoscopic surgery, open surgery, or combined laparoscopic-endoscopic approach) at Beijing Friendship Hospital.

Критерии исключения

  • pregnant or breastfeeding women;
  • Preoperative or intraoperative diagnosis remained indeterminate due to insufficient pathological or imaging evidence, such that the patient could not be clearly classified as early gastric cancer prior to treatment;
  • Critical clinical data were severely incomplete or missing；
  • Completely lost to follow-up with no available information to confirm survival status.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Friendship Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07747688 · 2026-P2-266-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗