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Идёт набор NCT06396533

Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)

— Наблюдательное Urothelial Carcinoma Muscle Invasive Bladder Urothelial Carcinoma Non-Muscle Invasive Bladder 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma, Non-Muscle Invasive Bladder Urothelial Carcinoma. Базовые параметры: от 18 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy

Обзор

This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy. Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.

Подробное описание

The principle outcome of this study is to determine the negative predictive value (NPV) of finding no muscle invasive (pT2) tumor in seeT0 patients with a negative result on the ctDNA assay prior to radical cystectomy.

Eligible candidates for radical cystectomy and INSITE trial:

* Patients with high grade T1 urothelial carcinoma who elect for "early" /upfront cystectomy * Patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who have relapsed or are refractory / unresponsive to intravesical therapy and have elected to undergo cystectomy * cT2-T3 muscle invasive urothelial carcinoma (irrespective of receipt of neo-adjuvant chemotherapy) Prior to cystectomy, tissue (transurethral resection of bladder tumor), urine and blood samples will be obtained at baseline for urine biopsy, ctDNA testing and future correlative studies.

After anesthetic induction for radical cystectomy, the patient will undergo rigid cystoscopy with targeted transurethral resection (TUR) of visible tumor or tumor bed, and two additional random bladder biopsies of normal-appearing bladder mucosa. Urine and blood samples will be obtained day of procedure for utilization for urine biopsy, ctDNA, and future correlative studies.

Following cystectomy, a diagnostic testing panel of pre-cystectomy cystoscopic and biopsy findings, ctDNA, and urine biopsy will be compared to final pathologic specimen.

Blood samples will be obtained 4-6 weeks (±2 weeks) post-procedure and 6 months (±1 month) post-procedure for analysis and ctDNA for post-procedure surveillance and other additional correlative studies. Additional blood sample collections at 12 months and 24 months post-procedure are optional.

Первичные конечные точки

  • Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence [Срок оценки: 2 years]
  • Utility of a DNA test for muscle-invasive bladder cancer presence [Срок оценки: 2 years]
Вторичные конечные точки (2)
  • Accuracy of surgical specimen DNA test to predict muscle-invasive disease [Срок оценки: 2 years]
  • Statistical accuracy evaluation of blood-based ctDNA assay for muscle-invasive bladder cancer presence [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Properly counselled patients with high grade T1 disease who elect for cystectomy
  • Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy
  • cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy
  • Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected).
  • Male or female patients age >=18 years at the time of consent.
  • Able and willing to comply with study requirements.
  • Patients must have a non-contrast phase component for CT scans of chest/abdomen/pelvis either pre-existing (prior to accrual) or obtained during the screening process.
  • Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy.
  • Ability to understand and willingness to sign a written informed consent and HIPAA authorization document.

Критерии исключения

  • Patients who undergo cystectomy with non-curative intent will be excluded.
  • Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.
  • Patients who are pregnant or nursing.

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

США · 2 центра
  • University of Nebraska Medical Center — Omaha
  • Fox Chase Cancer Center — Philadelphia

Идентификаторы

NCT: NCT06396533 · GU-222, 24-4001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗