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Идёт набор NCT06059963

A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation

— Наблюдательное Colorectal Cancer Advanced Adenocarcinoma

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: Signal-C™.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Advanced Adenocarcinoma. Базовые параметры: 45 лет — 84 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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Обзор

To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) in an average risk screening population for 45 and over.

Вмешательства

  • Устройство Signal-C™
    Signal-C™ is a qualitative next generation sequencing-based in vitro diagnostic assay that uses targeted hybridization-based capture next-generation sequencing together with bioinformatics and machine learning algorithm for detection and combination of methylation and fragmentation associated DNA marker regions. Signal-C™ utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected via venipuncture in Streck Cell-Free DNA Blood Collection Tubes (BCTs).

Первичные конечные точки

  • Primary Objective [Срок оценки: 1 year]
Вторичные конечные точки (1)
  • Secondary Objective [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Subjects aged 45-84 years at time of consent
  • Intended to undergo a standard-of-care screening colonoscopy
  • Considered by a physician or healthcare provider as being of 'average risk' for CRC
  • Willing to consent to blood draw prior to bowel preparatory procedures or undergoing colonoscopy ideally within 90 days of the date of the investigational blood draw.
  • Willing to consent to follow-up for one year as per protocol
  • Able and willing to sign informed consent

Критерии исключения

  • Undergoing colonoscopy for investigation of CRC risk symptoms
  • Has undergone colonoscopy within preceding 9 years
  • Positive FIT/FOBT result within the previous 12 months (+/- 3 months)
  • Has completed Cologuard or Epi proColon testing within the previous 3 years.
  • Has undergone a CT colonography in the prior 4 years.
  • History of colorectal cancer.
  • History of any malignancy within prior 5 years.
  • Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
  • Positive family history of colorectal cancer, defined as having a first- degree relative (parent, sibling, or child) with CRC diagnosed at age <60 years or with more than one first-degree relative diagnosed with CRC at any age.
  • Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\]).
  • Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
  • Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
  • Known pregnancy at informed consent, blood sample collection, and during study participation.
  • Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy.

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
  • Gastroenterology Consultants of SW Virginia — Raonoke

Идентификаторы

NCT: NCT06059963 · CRC-US-003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗