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Идёт набор NCT07514897

Detecting CREPT in Urine for Bladder Cancer Diagnosis and Monitoring

— Наблюдательное Bladder 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Bladder Cancer. 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
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Официальное название

Detection of CREPT Expression in Exfoliated Urothelial Cells for Early Diagnosis and Recurrence Monitoring of Bladder Cancer

Обзор

This study will, for the first time, establish a non-invasive diagnostic model for bladder cancer based on CREPT expression levels in exfoliated urothelial cells using a multicenter cohort, and validate its value in the non-invasive diagnosis and recurrence monitoring of bladder cancer. Its high sensitivity is expected to overcome the technical limitations of existing biomarkers and provide an innovative solution for establishing an integrated precision diagnosis and treatment system encompassing "screening, diagnosis, and monitoring."

Подробное описание

The main research content of this project will be carried out from the following aspects: (1) Establish an exploratory cohort comprising patients with bladder cancer, patients with benign urological diseases, and healthy individuals. The exploratory cohort will be randomly divided into a training cohort and an internal validation cohort in a 2:1 ratio. Using the training cohort, a non-invasive detection method for bladder cancer based on CREPT expression in exfoliated urothelial cells will be developed, and a non-invasive diagnostic model for bladder cancer based on CREPT expression in exfoliated urothelial cells will be constructed. The diagnostic performance of the model will then be validated using the internal validation cohort; (2) Establish an external validation cohort including patients with bladder cancer, benign urological diseases, and healthy individuals to evaluate the clinical diagnostic performance of the model; (3) Enroll patients with bladder cancer undergoing follow-up cystoscopy after Transurethral Resection of Bladder Tumor (TURBT) and patients requiring repeat TURBT to establish a recurrence monitoring cohort, and evaluate the performance of this diagnostic model in predicting bladder cancer recurrence.

Первичные конечные точки

  • Discrimination of the diagnostic model [Срок оценки: Short-term follow-up for 6 months, with follow-ups conducted at 3 months and 6 months post-enrollment; long-term follow-up for 1 year, with an additional follow-up at 12 months post-enrollment.]

Критерии участия

Критерии включения

  • (1) Patients diagnosed with or suspected of having bladder cancer; (2) Patients with benign urological diseases, including ureteral calculi, bladder calculi, cystitis, and ureteral stricture; (3) Consent to the use of experimental urine specimens and tissue specimens; (4) Aged 18 to 75 years; (5) Willing to sign informed consent, comply with the protocol, demonstrate good adherence, and cooperate with follow-up visits.

Критерии исключения

  • (1) History of other malignant tumors within 5 years or prior receipt of any anti-cancer treatment; (2) Urothelial carcinoma coexisting with other genitourinary tumors (e.g., renal cell carcinoma or prostate cancer); (3) Non-standard procedures for sample collection or storage; (4) Incomplete relevant information of the subject; (5) Patients with insufficient communication, comprehension, or cooperation, or poor compliance, who cannot guarantee completion of follow-up as required; (6) Subjects deemed by the investigator to be unsuitable for participation in this clinical trial for any other reasons, leading to withdrawal from the study.

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
  • National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences — Пекин

Публикации

  • Li J, Deng Z, Soerensen SJC, Kachuri L, Cardenas A, Graff RE, Leppert JT, Langston ME, Chung BI. Ambient air pollution and urological cancer risk: A systematic review and meta-analysis of epidemiological evidence. Nat Commun. 2024 Jun 15;15(1):5116. doi: 10.1038/s41467-024-48857-2. PMID 38879581

Идентификаторы

NCT: NCT07514897 · NCC5785

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗