An Observational Study on Postoperative Symptoms After Thyroidectomy (POS-T)
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: Thyroid Cancer. Базовые параметры: от 19 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
- South Korea
- 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
A Prospective Multi-centered Observational Study on Postoperative Symptoms After Thyroidectomy (POS-T) in Patients With Thyroid Cancer
Обзор
This observational study aimed to evaluate the safety and efficacy of postoperative management in patients with thyroid cancer who received subtotal or total thyroidectomy.
Подробное описание
1. Characteristic analysis of improvement in quality of life and symptoms after surgery in cancer patients 2. Multifaceted symptom evaluation of cancer patients visiting medical institutions 3. Evaluation of effectiveness and safety of treatment for postoperative symptoms in thyroid cancer patients 4. Analysis of the effectiveness and prognosis of cancer-related treatment for each patient with cancer 5. Analysis of prognostic factors for disease-free survival and overall survival of cancer patients
Among adult men and women aged 19 years or older who have been diagnosed with thyroid cancer, who have undergone partial or total thyroidectomy and visited the hospital for postoperative management, the characteristics of the visiting patient, quality of life, characteristics of cancer-related symptoms, and treatment effectiveness, We intend to conduct a prospective observational study to evaluate safety and its relationship with prognosis. In addition, we aim to form the basis for follow-up research through the establishment of an Oriental medicine cancer cohort and database.
Первичные конечные точки
- THYCA-QoL score at the time of discharge (1w) of hospitalization performed for postoperative management purposes [Срок оценки: At the end of week 1(each cycle is 7days)]
Вторичные конечные точки (8)
- Change in THYCA-QoL over time series [Срок оценки: At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month]
- EORTC-QLQ-C30 [Срок оценки: At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month]
- BCQ [Срок оценки: At the end of Day 1, week 1, week 2]
- CHPIQ [Срок оценки: At the end of Day 1, week 1, week 2]
- MDASI-Core [Срок оценки: At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month]
- Oral epithelial cell-based whole genome analysis [Срок оценки: Day 1]
- overall survival [Срок оценки: At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month]
- Adverse events [Срок оценки: At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month]
Критерии участия
Критерии включения
- 19 years of age or older
- Those who have been confirmed to have a malignant tumor of the thyroid gland by biopsy or imaging
- Subjects who have undergone partial thyroidectomy or total resection within 1 month
- Those who have agreed to the implementation of Chinese medicine treatment
- The Eastern Cooperative Oncology Group(ECOG) performance status 0-3
- Those who understand the content of the study and agree to participate in the study
Критерии исключения
- ○ When it is judged that other diseases other than cancer (dementia, cerebrovascular disease, severe organ failure, etc.) may have a significant effect on the decline of physical function
- When it is judged that the life expectancy is less than 3 months and sufficient follow-up cannot be carried out
- When emergency or major surgery or surgical intervention is required that takes precedence over postoperative treatment
- Pregnant and lactating women
- Other researchers who are judged to be unsuitable for research
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
South Korea · 3 центра
- Bundang Cha Hospital — Gyeonggi-do
- Ilsan Cha Hospital — Gyeonggi-do
- Gangnam Cha Hospital — Seoul
Идентификаторы
NCT: NCT06158360 · ICICC-OS-23-01