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Идёт набор NCT06308328

A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis

— Наблюдательное Radiation-induced Oropharyngeal Mucositis Swallowing-induced Breakthrough Pain

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain. 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
Китай
Следующий шаг
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Официальное название

A Real-world Observational Study of a Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Predicting Radiation-induced Oropharyngeal Mucositis in Patients With Nasopharyngeal Carcinoma

Обзор

The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance in locally advanced NPC. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further assess the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.

Подробное описание

Swallowing-induced breakthrough pain as a prominent clinical challenge for radiation-induced oropharyngeal mucositis, occurs in almost all patients with nasopharyngeal carcinoma (NPC) undergoing radiotherapy, and has a significant impact on patients' quality of life and treatment outcomes. Radiation-induced oropharyngeal mucositis is closely related to the irradiated dose and volume, and the performance of the predictive models for its occurrence and severity established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory. Thus, it is difficult to carry out risk assessment, precise screening and early intervention through dosimetric parameters, thereby reducing the occurrence of severe radiation-induced oropharyngeal mucositis. The investigators defined a delineation method based on the mucosal areas of radiation-induced injury resulting in swallowing-induced breakthrough pain in locally advanced NPC, and our preliminary results demonstrated that the predictive model exhibited better overall performance. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.

Первичные конечные точки

  • The AUC of the predictive model [Срок оценки: Through study completion, up to 3 years]
Вторичные конечные точки (7)
  • The accuracy of the predictive model [Срок оценки: Through study completion, up to 3 years]
  • The sensitivity of the predictive model [Срок оценки: Through study completion, up to 3 years]
  • The specificity of the predictive model [Срок оценки: Through study completion, up to 3 years]
  • The positive predictive value of the predictive model [Срок оценки: Through study completion, up to 3 years]
  • The negative predictive value of the predictive model [Срок оценки: Through study completion, up to 3 years]
  • The F1 score of the predictive model [Срок оценки: Through study completion, up to 3 years]
  • The important predictors of severe oropharyngeal mucositis in the predictive model [Срок оценки: Through study completion, up to 3 years]

Критерии участия

Критерии включения

  • Provide informed written consent.
  • Age ≥ 18 years.
  • Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy.
  • Complete and continuous records of oral / oropharyngeal mucositis grading, and self-reported swallowing-induced breakthrough pain.

Критерии исключения

  • Existence of poor oral hygiene, untreated dental or periodontal diseases, and metal dental restorations.
  • Current untreated or unresolved conditions like unstable heart diseases requiring treatment, and poorly controlled diabetes mellitus.
  • Body mass index (BMI) <18.5.
  • Unsuitable to participate in current study, according to researchers' assessment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 10 центров
  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University — Гуанчжоу
  • Nanfang hospital, Southern medical university — Гуанчжоу
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Гуанчжоу
  • Sun Yat-sen University Cancer Center — Гуанчжоу
  • The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
  • Yuebei People's Hospital — Shaoguan
  • Peking University Shenzhen Hospital — Шэньчжэнь
  • The Fifth Affiliated Hospital, Sun Yat-sen University — Zhuhai
  • … и ещё 2 центра

Идентификаторы

NCT: NCT06308328 · NFEC-2024-090

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗