An Exploratory Study on Gene Methylation Detection of Colorectal Cancer

Официальное название

An Exploratory Study on Gene Methylation Detection of Colorectal Cancer（CRC）

Обзор

The goal of this exploration study is to evaluate the performance of a colorectal cancer (CRC) early screening model based on the DNA methylation technology platform. The study focuses on individuals over the age of 40 and aims to identify and verify methylation biomarkers for colorectal cancer using stool samples . The main question it aims to answer is: Can a DNA methylation-based model effectively detect colorectal cancer and adenoma in individuals over 40 using non-invasive stool samples? Participants will provide stool samples for methylation analysis. The study results will be used solely for internal product performance evaluation and optimization by the sponsor and will not be used for product registration or influence any clinical diagnosis.

Вмешательства

• Диагностический тест This study does not require intervention trials
  This study does not require intervention trials

Первичные конечные точки

• human stool gene methylation [Срок оценки: 2024.12-2025.8]

Критерии участия

Критерии включения

• Sample Source: Hospital physical examination, outpatient, and inpatient patients;
• Patient Information: Patient information (such as age, hospital ID number, gender, clinical diagnosis, colonoscopy and pathology results) is traceable;
• Age Requirement: ≥ 40 years old;
• Sampling Time Requirement: Stool and plasma samples must be collected within 3 months prior to colonoscopy (stool samples are preferred).

Критерии исключения

• Unclear Sample Collection Information: Samples with unclear collection time, or stool samples not collected within 3 months prior to colonoscopy, or samples with incomplete clinical information that cannot be traced;
• Non-compliance with Sample Requirements: Samples that do not meet the collection and storage requirements;
• History of Disease: Subjects with a history or treatment of colorectal cancer (CRC) or advanced precancerous lesions;
• Insufficient Sample Volume: Samples with insufficient volume that cannot meet the requirements of the assessment system testing;
• Hereditary Diseases: Subjects with a diagnosis or family history of the following diseases:Familial adenomatous polyposis (FAP), including attenuated FAP and Gardner syndrome;Hereditary nonpolyposis colorectal cancer syndrome (HNPCC or Lynch syndrome);Other hereditary cancer syndromes, including but not limited to Peutz-Jeghers syndrome, MYH-associated polyposis (MAP), Turcot syndrome (or Crail syndrome), Cowden syndrome, juvenile polyposis, neurofibromatosis, or familial proliferative polyposis (FAP);
• Inflammatory Bowel Disease (IBD): Subjects with a diagnosis or personal history of IBD, including chronic ulcerative colitis and/or Crohn's disease;
• Cronkhite-Canada Syndrome: Subjects with a diagnosis of Cronkhite-Canada syndrome.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhejiang Provincial People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT07033156 · QT2024274

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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