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Набор скоро начнётся NCT06528223

Research of the Application of Artificial Intelligence Model "PANDA"

Без фазы С лечением Pancreatic 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: biopsy or operation.
Кому может быть актуально
Состояния в реестре: Pancreatic Cancer. Базовые параметры: Без ограничений · 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 →
Официальное название

Research of the Application of Artificial Intelligence Model 'PANDA': A MultiCenter, Prospective Randomized Controlled Clinical Trial

Обзор

The research objective of this project is to conduct a large-scale and prospective real-world validation of the Pancreatic Cancer Screening Model PANDA, which was developed based on deep learning and plain CT scans in previous studies. This validation will be carried out across different scenarios at the First Affiliated Hospital of Zhejiang University, leveraging clinical big data. The goal is to verify the model's role in suggesting and supplementing the diagnosis of PDAC in clinical practice, thereby laying the groundwork for large-scale opportunistic screening of PDAC.

Подробное описание

This study focuses on potential cases of clinically missed PDAC. It aims to evaluate the pancreatic cancer screening model PANDA, based on deep learning and non-enhanced CT scans, in a prospective real-world cohort from multiple clinical scenarios at the First Affiliated Hospital of Zhejiang University. The study will track patients with negative imaging reports but positive PANDA model findings, verifying their pathology through gold standard examinations to assess PANDA's efficacy. It aims to validate the model's utility, applicability, sensitivity, and specificity.

Based on these objectives, the study will undertake the following:

1. Utilize PANDA's output to categorize enrolled patients into nonPDAC, PDAC, and normal groups. It will compare these results with imaging findings. Patients identified as PANDA-positive for PDAC but without corresponding imaging evidence of pancreatic lesions, or those with imaging suggesting pancreatic findings but lacking subsequent clinical intervention, will be categorized for follow-up. These patients will be recalled to the hospital for further examination and diagnosis at Zhejiang University's First Affiliated Hospital. For PDAC-positive cases identified during secondary examinations, standard clinical procedures such as MDT will be followed for confirmation of pathology. Patients identified as PDAC-negative during secondary examinations will undergo extensive follow-up for up to two years to determine outcomes, thus validating PANDA's sensitivity and specificity. Patients identified by PANDA as nonPDAC-positive but lacking corresponding pancreatic findings in imaging will undergo a review by hepatobiliary pancreatic surgeons to confirm accuracy. Those reported as normal by PANDA but with imaging suggesting pancreatic abnormalities will undergo secondary review by surgical experts to confirm or rule out false negatives by PANDA. 2. For true positive PDAC cases identified by PANDA, medical records will be collected (tumor marker levels, patient symptoms, resectability grading, TNM staging, etc.) for comparison with corresponding indicators from PDAC patients identified through the Standard Order of Clinic SOC. This aims to validate PANDA's capability in early detection and identification of lesions in pancreatic cancer development.

Вмешательства

  • Диагностический тест biopsy or operation
    To obtain a biopsy pathology or surgical pathology according to the clinical process of PDAC.

Первичные конечные точки

  • OS [Срок оценки: From diagnosis of PDAC to 3 years later]
Вторичные конечные точки (3)
  • TNM stage [Срок оценки: 1 day (evaluate through CT imaging before surgery)]
  • Resectability grading [Срок оценки: 1 day (evaluate through CT imaging before surgery)]
  • Tumor markers [Срок оценки: Immediately after recall]

Критерии участия

Критерии включения

  • The participants have undergone chest and/or abdominal plain CT scans at outpatient, inpatient, or physical examination centers

Критерии исключения

  • Chest CT scan without pancreatic coverage
  • Patients undergoing thoracic/abdominal surgical procedures that affect or alter the anatomical display of the pancreas (esophageal/gastric/pancreatic/vascular/ERCP postoperative, etc.)
  • Scanning non-standard examinations, such as significant respiratory motion artifacts

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Диагностика

Центры проведения

Китай · 2 центра
  • the First Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу
  • the First Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT06528223 · PANDA-PRO

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗