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Идёт набор NCT07037589

Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed?

— Наблюдательное Hematuria Acute Cystitis With Hematuria Bladder Cancer Urothelial Carcinoma

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: investigation setting (cystoscopy + CTU + cytology), Cystoscopy - CTU - cytology (if needed).
Кому может быть актуально
Состояния в реестре: Hematuria, Acute Cystitis With Hematuria, Bladder Cancer, Urothelial Carcinoma. Базовые параметры: 18 лет — 110 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
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Официальное название

Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed? A Prospective Multicenter Study. BLUSH Trial

Обзор

This prospective multicenter observational study evaluates whether women ≥50 years with isolated acute hemorrhagic cystitis (AHC) and macroscopic hematuria require full malignancy workup. All participants undergo standard diagnostics (cystoscopy, CT urography, cytology), with 12-month follow-up for cancer detection. The aim is to identify low-risk patients where invasive investigations may be safely avoided.

Подробное описание

The BLUSH trial is a prospective, multicenter, observational study investigating whether full malignancy workup is necessary in women ≥50 years presenting with isolated acute hemorrhagic cystitis (AHC) and macroscopic hematuria. AHC is defined as macroscopic hematuria accompanied by acute lower urinary tract symptoms (dysuria, frequency, urgency) of less than one week's duration. Women with prior urological malignancies, significant comorbidities, or impaired consent capacity are excluded.

All enrolled patients undergo standardized initial assessment including full clinical history (smoking, family history, comorbidities), physical examination, urinalysis, urine culture, cystoscopy, CT urography, and cytology when indicated. Participants are stratified into AHC and non-AHC groups based on symptomatology and laboratory findings. Data collection includes demographics, symptom duration, urine findings, cancer diagnoses (type, stage, grade), treatment details, and clinical outcomes.

Patients are followed for a minimum of 12 months via medical record review to capture delayed cancer diagnoses. Data are pseudonymized and stored securely under GDPR regulations. The primary outcome is the incidence of urological malignancy within one year. Secondary outcomes include time to diagnosis, proportion of avoidable invasive procedures, and accuracy of the AHC classification in predicting cancer risk.

The study aims to support individualized risk-based management in women with hematuria.

Вмешательства

  • Процедура investigation setting (cystoscopy + CTU + cytology)
    Observational study. All patients in this group undergo standard diagnostic evaluation including cystoscopy, CT urography, and urine cytology (if clinically indicated), performed during initial assessment for acute macroscopic hematuria.
  • Процедура Cystoscopy - CTU - cytology (if needed)
    All patients in this group undergo standard diagnostic evaluation including cystoscopy, CT urography, and urine cytology (if clinically indicated), performed during initial assessment for atypical or chronic presentations of macroscopic hematuria.

Первичные конечные точки

  • Incidence of urological malignancy [Срок оценки: At least 12 months from study inclusion.]
Вторичные конечные точки (3)
  • Time to cancer diagnosis [Срок оценки: At least 12 months from study inclusion.]
  • Proportion of potentially avoidable invasive procedures in AHG [Срок оценки: At least 12 months from study inclusion.]
  • Sensitivity and specificity of AHC classification [Срок оценки: At least 12 months from study inclusion.]

Критерии участия

Критерии включения

  • Women ≥50 years of age.
  • Macroscopic hematuria.
  • Presenting for evaluation within the SCP for macroscopic hematuria.
  • Ability to provide informed consent.

Критерии исключения

  • Prior diagnosis of bladder cancer, renal cancer, or upper tract urothelial carcinoma (UTUC).
  • Cognitive impairment preventing informed consent.
  • Ongoing or recent treatment for urological malignancy.
  • Serious comorbidities affecting participation or safety.
  • Pregnant women.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швеция · 1 центр
  • Uddevalla Hospital — Uddevalla

Идентификаторы

NCT: NCT07037589 · BLUSH trial

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗