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Набор скоро начнётся NCT06276153

Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer

— Наблюдательное Biliary Tract Diseases Gallbladder Cancer Gallbladder Neoplasms

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 interventions.
Кому может быть актуально
Состояния в реестре: Biliary Tract Diseases, Gallbladder Cancer, Gallbladder Neoplasms. Базовые параметры: 18 лет — 74 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The aim of the study is to establishing a standardized clinical information database for patients with malignant tumors of gallbaldder. Based on the database, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy.

Подробное описание

From the date of commencement of the study, patients who presented to the participating medical institutions in the study and were clinically diagnosed as gallbladder cancer, and who met the inclusion criteria and did not meet any of the exclusion criteria, were enrolled in the study cohort after signing an informed consent form.

The research objectives of this study mainly include establishing a structured dataset standard for gallbladder cancer based on the diagnosis and treatment norms and clinical pathways and carrying out clinical registration research on gallbladder cancer and build a specific disease cohort

The outcome indicators of this study included overall survival time OS, recurrence-free survival time PFS, R0 resection rate of patients treated with biliary malignancy, and objective response rate ORR. The main measurement indicators of this study include the patient's demographic information, past history, life history, admission, preoperative examination information, surgery, postoperative situation, discharge, follow-up, outcome indicators, routine examination results of biological samples and multi-omics sequencing results, the above data are derived from the original records of prospective case questionnaires, the original records of patients' electronic medical records and the examination results of patients' biological samples. The outcome of follow-up was defined as patients having been followed up for five years, or having a patient lost to follow-up or dying during follow-up.

Вмешательства

  • Другое no interventions
    retrospective registry cohort with no other specific interventions

Первичные конечные точки

  • overall survival [Срок оценки: From date of enrollment until the date of death from any cause, whichever came first, assessed up to 5-years.]
Вторичные конечные точки (1)
  • progression-free survival [Срок оценки: From date of enrollment until the date of first documented progression from any cause, whichever came first, assessed up to 5-years.]

Критерии участия

Критерии включения

  • Sign informed consent, have good compliance, and be willing to accept follow-up and provide blood samples
  • Age 18-74 years old, gender is not limited
  • Clinical diagnosis of gallbladder cancer, including unoperated patients preliminarily diagnosed as gallbladder cancer according to the results of imaging examinations and laboratory tests, or pathological examination of patients treated with surgery confirmed as malignant tumors of the gallbladder.
  • The primary tumor is located in gallbladder floor, gallbladder body, gallbladder neck or gallbladder duct.
  • Karnofsky performance score greater than 50.

Критерии исключения

  • Patients with gallbladder cancer, gallbladder cancer foci are not primary lesions.
  • Patients with gallbladder cancer, combined with serious central nervous system diseases, respiratory diseases, autoimmune diseases, chronic renal insufficiency and other diseases, long-term use of immunosuppressants, combined with serious uncontrolled infections.
  • Patients with gallbladder cancer, who also have active cardiovascular and cerebrovascular diseases, have cerebrovascular accidents, myocardial infarction, unstable angina pectoris, or grade II. or above congestive heart failure according to the standards of the New York Heart Association, and require serious arrhythmias requiring drug treatment.
  • Patients with gallbladder cancer, women of childbearing age who have a positive blood pregnancy test or have not had a pregnancy test, pregnant or breastfeeding women.
  • The patient is participating in other therapeutic clinical trials where treatment measures cannot be clarified or treatment information cannot be collected .

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06276153 · CRGGCext

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗