Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreatic Cystic Fluid Samples

Официальное название

Construction of Molecular Diagnostic Marker Models for Pancreatic Cystic Tumors Based on CfDNA Methylation Sequencing and Proteomic Analysis of Pancreatic Cystic Fluid Samples

Обзор

The goal of this observational study is to test in patients with cystic tumor of pancreas. The main questions it aims to answer are: Screening of molecular diagnostic markers for pancreatic cystic tumors by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic assays to distinguish benign from malignant and mucinous/non-mucinous, correlate with pathological features, and find molecular features associated with the degree of malignancy. Participants will Provide post-operative cyst fluid specimens.

Подробное описание

Patients with pancreatic cystic tumors were divided into control, mucinous tumor and non-mucinous tumor groups, and cfDNA molecules and protein molecules that were significantly altered between different groups were found by cfDNA methylation sequencing of pancreatic cystic fluid and proteomic detection techniques. Multi-omics analysis was performed to construct a more efficient molecular diagnostic marker model. Correlating models with pathological features to find molecular features associated with the degree of malignancy.

Вмешательства

• Диагностический тест cfDNA methylation sequencing and proteome analysis
  Sequencing of cfDNA methylation and proteomic analysis of two sets of capsular fluid samples

Первичные конечные точки

• Types and concentrations of cfDNA and proteins contained in the vesicular fluid [Срок оценки: 2023-11-31]

Вторичные конечные точки (3)

• Establishment of a diagnostic model for cystic tumors of the pancreas [Срок оценки: 2023-11-31]
• Establishing a model for the identification of mucus and non-mucus [Срок оценки: 2023-11-31]
• Development of a progressive benign malignancy prediction model [Срок оценки: 2023-11-31]

Критерии участия

Критерии включения

• Subjects are ≥ 18 years old, regardless of gender;
• Preoperative imaging examination (EUS, CT, MRI) diagnosed cystic mass of pancreas and suspected cystic tumor;
• Subjects voluntarily accepted radical resection of pancreatic cystic tumors;
• Subjects or family members voluntarily sign the informed consent form for clinical research.

Критерии исключения

• The excised sample does not contain cystic components, or the cystic fluid cannot be collected;
• Receive tumor-related treatment (radiotherapy, chemotherapy, immunotherapy, etc.) before operation;
• Receive antibiotic treatment within 1 week before operation;
• Subjects refused to accept radical resection of pancreatic cystic tumor, or had any situation that they could not accept radical resection of pancreatic cystic tumor;
• The subjects or their families refused to sign the informed consent form for clinical research.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• Changhai Hospital — Шанхай

Идентификаторы

NCT: NCT05737953 · WKX2023-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗