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Набор скоро начнётся NCT06607614

A Predictive Model Based on Quantitative Fecal Immunochemical Test Can Stratify the Risk of CRC in an Organized Screening Program

— Наблюдательное Colorectal Cancer Screening

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: Colorectal Cancer Screening Fecal Immunochemical Test.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer Screening. 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
Список центров уточняется — проверьте первичный протокол.
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

Prioritizing Resumption of Colorectal Screening After COVID

Обзор

The COVID-19 pandemic has disrupted every aspect of medical care, including screening programs and preventive medical care . Organized FIT-based colorectal cancer screening programs make no exception, since their efficacy depends on a multi-tiered series of interventions that were hampered by the pandemic at multiple levels. In detail, the first level of intervention, namely population based FIT tests distributed to the population, has seen a dramatic decrease of number of tests performed for both organizational reasons (i.e. less personnel deployed to testing sites) and for failure to present fecal samples from patients for fear of contagion or impossibility to reach the drop-off sites for state-imposed limitations. Secondly, the referral of FIT positive patients to subsequent colonoscopy was stopped or delayed since endoscopy services have been undergoing only emergent and urgent procedures. Thirdly, patients diagnosed with advanced neoplasia or cancer have seen their endoscopic or surgical removal procedures delayed or canceled . Regarding post-FIT colonoscopy workup, European Screening Guidelines recommend a 30-day maximum span between a positive FIT test and subsequent colonoscopy. It is well known that any delay in post-FIT+ colonoscopy results in an increase in advanced neoplasia and colorectal cancer, that reaches dramatic levels after 6 months . Our purpose is to develop and validate, using the quantitative level of faecal hemoglobin found in FIT, a simple scoring system to effectively sub-stratify CRC risk of FIT positive patients.

Вмешательства

  • Другое Colorectal Cancer Screening Fecal Immunochemical Test
    Fecal Immunochemical Test

Первичные конечные точки

  • Colorectal cancer rate in the different risk groups [Срок оценки: 12 months]
Вторичные конечные точки (2)
  • Advanced adenoma rate in the different risk group [Срок оценки: 12 months]
  • Any adenoma rate in the different risk groups [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • All FIT+ patients awaiting to be scheduled for colonoscopy workup. Patients will be invited to undergo a colonoscopy, and depending on its outcome, patients are referred for surgery, postcolonoscopy surveillance, or further rounds of FIT.

Критерии исключения

  • Individuals with a prevalent diagnosis of CRC are excluded from the program, as well as patients that have already undergone a high quality colonoscopy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Cubiella J, Digby J, Rodriguez-Alonso L, Vega P, Salve M, Diaz-Ondina M, Strachan JA, Mowat C, McDonald PJ, Carey FA, Godber IM, Younes HB, Rodriguez-Moranta F, Quintero E, Alvarez-Sanchez V, Fernandez-Banares F, Boadas J, Campo R, Bujanda L, Garayoa A, Ferrandez A, Pinol V, Rodriguez-Alcalde D, Guardiola J, Steele RJ, Fraser CG; COLONPREDICT study investigators. The fecal hemoglobin concentration PMID 28187494
  • Park CH, Jung YS, Kim NH, Park JH, Park DI, Sohn CI. Usefulness of risk stratification models for colorectal cancer based on fecal hemoglobin concentration and clinical risk factors. Gastrointest Endosc. 2019 Jun;89(6):1204-1211.e1. doi: 10.1016/j.gie.2019.02.023. Epub 2019 Feb 25. PMID 30817918
  • Kim NH, Lim JW, Kim S, Lim JY, Kim W, Park JH, Park DI, Sohn CI, Jung YS. Association of time to colonoscopy after a positive fecal test result and fecal hemoglobin concentration with risk of advanced colorectal neoplasia. Dig Liver Dis. 2019 Apr;51(4):589-594. doi: 10.1016/j.dld.2018.12.008. Epub 2018 Dec 23. PMID 30733186
  • Zorzi M, Hassan C, Capodaglio G, Baracco M, Antonelli G, Bovo E, Rugge M. Colonoscopy later than 270 days in a fecal immunochemical test-based population screening program is associated with higher prevalence of colorectal cancer. Endoscopy. 2020 Oct;52(10):871-876. doi: 10.1055/a-1159-0644. Epub 2020 Apr 30. PMID 32356282

Идентификаторы

NCT: NCT06607614 · 6404

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗