Меню
Идёт набор NCT07154173

Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer

— Наблюдательное Rectal Neoplasms Colon Neoplasms Microbiota Metagenome

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: Biospecimen Collection Procedure.
Кому может быть актуально
Состояния в реестре: Rectal Neoplasms, Colon Neoplasms, Microbiota, Metagenome. Базовые параметры: 18 лет — 75 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Colorectal cancer (CRC) is one of the most common and deadly cancers worldwide. About 1 in 4 people with CRC already have cancer spread (metastasis) when first diagnosed, and about half develop spread during their illness. Recent research shows that bacteria living in the gut and even within tumors might play an important role in how cancer spreads. The goal of this study is to better understand how bacteria might influence the spread of colorectal cancer. The main questions the investigators aim to answer are: Are there differences in bacteria between people whose cancer has spread and those whose cancer has not spread? Could certain bacteria help predict which cancers might spread? To answer these questions, the investigators will: Collect different types of samples from participants: Tumor tissue Normal tissue near the tumor Tissue from where cancer has spread Stool samples before surgery Study the bacteria in these samples using advanced testing methods Compare bacterial patterns between different groups People can take part in this study if they: Are between 18 and 75 years old Have colorectal cancer confirmed by doctors Have not taken antibiotics recently Do not have immune system problems This research may help us: Understand why some colorectal cancers spread Find new ways to predict which cancers might spread Develop better treatments for colorectal cancer

Вмешательства

  • Процедура Biospecimen Collection Procedure
    Collection of fecal samples from healthy volunteers, non-metastatic (M0) and metastatic (M1) colorectal cancer patients. Additionally, collection of tissue samples during surgery from operable patients (M0 and M1) for subsequent research analysis.

Первичные конечные точки

  • Intestinal Microbiota Diversity Differences Between Colorectal Cancer Patients With and Without Peritoneal Metastasis [Срок оценки: Fecal samples collected at patient's first hospital admission; tissue specimens collected during surgery. All specimens analyzed within 6 months after collection.]

Критерии участия

Критерии включения

  • Age between 18 and 75 years
  • Pathologically confirmed colorectal cancer
  • Clearly defined clinical staging: including imaging or pathologically confirmed metastatic colorectal cancer (stage M1) and colorectal cancer without distant metastasis (stage M0)
  • Expected survival ≥ 3 months
  • Voluntary participation and signed informed consent

Критерии исключения

  • Use of probiotics, antibiotics, or immunosuppressive agents within 1 month before surgery
  • Preoperative complete intestinal obstruction or gastrointestinal perforation
  • Intraoperative gastrointestinal perforation or tumor rupture
  • Previous history of gastrointestinal surgery (excluding colorectal cancer surgery, appendectomy, and cholecystectomy) or concurrent severe gastrointestinal diseases such as inflammatory bowel disease
  • Concurrent active systemic immune or infectious diseases, including severe allergies, rheumatoid arthritis, systemic lupus erythematosus, viral hepatitis, acquired immunodeficiency syndrome, etc.
  • Concurrent unhealed primary malignant tumors
  • Severe organ dysfunction or failure
  • Other conditions deemed unsuitable for this study by the investigator

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • The Sixth Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Публикации

  • Wirbel J, Pyl PT, Kartal E, Zych K, Kashani A, Milanese A, Fleck JS, Voigt AY, Palleja A, Ponnudurai R, Sunagawa S, Coelho LP, Schrotz-King P, Vogtmann E, Habermann N, Nimeus E, Thomas AM, Manghi P, Gandini S, Serrano D, Mizutani S, Shiroma H, Shiba S, Shibata T, Yachida S, Yamada T, Waldron L, Naccarati A, Segata N, Sinha R, Ulrich CM, Brenner H, Arumugam M, Bork P, Zeller G. Meta-analysis of fec PMID 30936547

Идентификаторы

NCT: NCT07154173 · MCRCGM-SYSU-2025-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗