Меню
Идёт набор NCT07446738

A Study to Investigate the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients

— Наблюдательное Chronic Rhinosinusitis With Nasal Polyps

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: Endoscopic Sinus Surgery (ESS).
Кому может быть актуально
Состояния в реестре: Chronic Rhinosinusitis With Nasal Polyps. Базовые параметры: Без ограничений · 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
Китай
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

PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese CRSwNP Patients

Обзор

This is a prospective, multicenter real-world study to describe the postoperative outcomes and quality of life, disease control and characteristics of patients who underwent surgery, as well as economic burden and post-operative treatment patterns in Chinese patients with CRSwNP recurrence.

Подробное описание

This is a prospective, multicenter real-world study to describe the postoperative outcomes and quality of life, disease control and characteristics of patients who underwent surgery, as well as economic burden and post-operative treatment patterns in Chinese patients with CRSwNP. Patients will receive standard medical care as determined by the treating physician at each site and undergo scheduled clinical assessments.

Approximately 200 patients diagnosed with CRSwNP by physicians and scheduled for surgical treatment will be enrolled across 20 centres in different regions of China.

Вмешательства

  • Процедура Endoscopic Sinus Surgery (ESS)
    This is a standard of care surgical procedure performed according to clinical routine. No experimental treatment or investigational drug is administered as part of this study.

Первичные конечные точки

  • • The observed and change from baseline of Sino-Nasal Outcome Test (SNOT)-22 score at week-52 [Срок оценки: week0-52]
  • • The observed and change from baseline of Modified Lund-Kennedy (MLK) score at week-52 [Срок оценки: week0-52]
Вторичные конечные точки (12)
  • Changes from baseline at each collection point: • VAS - Total sinus symptoms item [Срок оценки: week0-52]
  • Changes in NPS from baseline at each collection point [Срок оценки: week0-52]
  • Changes from baseline at each collection point: • VAS - Nasal blockage item [Срок оценки: week0-52]
  • Changes from baseline at each collection point: • SNOT-22 Smell/taste Item Score [Срок оценки: week0-52]
  • Changes from baseline at each collection point: • SNOT-22 Nasal Congestion Item Score [Срок оценки: week0-52]
  • Changes from baseline at each collection point: • Nasal Congestion Score (NCS) [Срок оценки: week0-52]
  • Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) Loss of Smell [Срок оценки: week0-52]
  • Changes from baseline at each collection point: • Nasal Airway Resistance (NAR) [Срок оценки: week0-52]
  • Pre-operative, 24-week post-operatively, and 52-week Lund-Mackay CT Scores [Срок оценки: week0-52]
  • Changes from baseline at each collection point: • SF-36((Short Form Health Survey) [Срок оценки: week0-52]
  • Changes from baseline at each collection point: • The Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score [Срок оценки: week0-52]
  • Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) sleep domain [Срок оценки: week0-52]

Критерии участия

Критерии включения

  • Participant must be 16 years of age or older, at the time of signing the informed consent.
  • Participants with a documented diagnosis of CRSwNP.
  • Endoscopic nasal polypectomy is performed during the screening period.
  • Voluntarily participate and sign the informed consent form as described in A 3.
  • No history or current psychiatric disorders, with normal cognitive functions including understanding, expression, and orientation.

Критерии исключения

  • Any significant disease or disorder that the investigator believes may place the patient at risk or may affect the study results or the patient's ability to participate in the study.
  • Currently participating in an interventional study.
  • Patients who are unable to independently complete questionnaires due to language barriers or mental status.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 18 центров
  • Research Site — Changchun
  • Research Site — Чанша
  • Research Site — Чэнду
  • Research Site — Гуанчжоу
  • Research Site — Гуанчжоу
  • Research Site — Гуанчжоу
  • Research Site — Haikou
  • Research Site — Куньмин
  • … и ещё 10 центров

Идентификаторы

NCT: NCT07446738 · D5242R00005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗