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Идёт набор NCT07069556

ColoSense Post-Approval Study

— Наблюдательное Colorectal Cancer (Diagnosis)

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: ColoSense.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer (Diagnosis). 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

ColoSense Post Approval Study

Обзор

The post-approval study (PAS) described here will supplement existing data generated in the CRC-PREVENT clinical trial. The primary outcomes of this supplemental study will include: clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV) of ColoSense.

Вмешательства

  • Устройство ColoSense
    multi-target stool RNA test

Первичные конечные точки

  • CRC Sensitivity [Срок оценки: Through study completion, an average of 5 years.]
  • AA Sensitivity [Срок оценки: Through study completion, an average of 5 years.]
  • SPL Sensitivity [Срок оценки: Through study completion, an average of 5 years.]
  • NEG Specificity [Срок оценки: Through study completion, an average of 5 years.]

Критерии участия

Критерии включения

  • Subject is male or female, ≥45 years of age (subjects aged 18-45 can be enrolled onto the clinical trial but are not eligible for primary endpoint analysis)
  • Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form
  • Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure
  • Subject is able and willing to undergo a colonoscopy after providing a stool sample

Критерии исключения

  • Subject had any precancerous findings on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size
  • Subject has a history or diagnosis of colorectal cancer
  • Subject has a history of aerodigestive tract cancer
  • Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals:
  • Fecal occult blood test or fecal immunochemical test within the previous twelve (12) months
  • FIT-DNA test within the previous 36 months
  • Subject has had a colonoscopy in the previous nine (9) years.
  • Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
  • Indication for colonoscopy was due to overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
  • Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
  • Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
  • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP)
  • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome")
  • Other hereditary cancer syndromes including but are not limited to:
  • Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome
  • Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis
  • Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Decentralized Study — St Louis

Идентификаторы

NCT: NCT07069556 · CT-PRT-0004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗