Набор по приглашению NCT07470658

Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy

— Наблюдательное Advanced Colorectal Cancer Colo-rectal Cancer Fecal Immunochemical Test

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: Colonoscopy Surveillance.
Кому может быть актуально: Состояния в реестре: Advanced Colorectal Cancer, Colo-rectal Cancer, Fecal Immunochemical Test. Базовые параметры: 45 лет — 74 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: Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

From Uncertainty to Evidence: A Randomized Controlled Trial for Optimal Surveillance in High-Risk Colonoscopy-Negative Individuals After Positive FIT

Обзор

Individuals with high fecal hemoglobin concentrations detected by fecal immunochemical testing (FIT) but negative findings on high-quality colonoscopy represent a clinically challenging population. Although colonoscopy is considered the gold standard diagnostic procedure, previous studies suggest that these individuals may still have an elevated long-term risk of colorectal cancer. This randomized controlled trial aims to determine the optimal surveillance strategy for this high-risk group by comparing two approaches: repeat FIT testing after two years versus direct colonoscopy after two years.

Подробное описание

In colorectal cancer screening programs based on fecal immunochemical testing (FIT), a subgroup of individuals presents with strongly positive FIT results but negative findings on subsequent high-quality colonoscopy. Despite the absence of detected adenomas or cancer, these individuals may remain at increased risk of colorectal cancer.

Currently, there is no consensus guideline regarding the optimal follow-up strategy for this population. Some clinicians recommend repeat colonoscopy, while others prefer non-invasive monitoring using FIT.

This pragmatic randomized controlled trial will compare two surveillance strategies:

Repeat FIT testing two years after enrollment

Direct colonoscopy two years after enrollment

The primary objective is to compare the detection rate of advanced colorectal neoplasia (ACN) between the two strategies. The results of this study may help establish evidence-based surveillance guidelines for this high-risk population.

Вмешательства

Диагностический тест Colonoscopy Surveillance
Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.

Первичные конечные точки

Detection rate of advanced colorectal neoplasia (ACN) [Срок оценки: 2 years]

Вторичные конечные точки (4)

Detection rate of any adenoma [Срок оценки: 2 years]
Detection rate of colorectal cancer [Срок оценки: 2 years]
Screening compliance rate [Срок оценки: 2 years]
Cost-effectiveness comparison between surveillance strategies [Срок оценки: 2 years]

Критерии участия

Критерии включения

Age 45-74 years
Quantitative FIT result with fecal hemoglobin ≥100 µg/g within the past two years
Negative high-quality colonoscopy following the positive FIT result
Ability to provide written informed consent