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Идёт набор NCT06979869

Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma

— Наблюдательное Esophageal Cancer

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: Multi-gene methylation testing, Multi-gene methylation testing, Multi-gene methylation testing, Multi-gene methylation testing.
Кому может быть актуально
Состояния в реестре: Esophageal Cancer. Базовые параметры: 18 лет — 75 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The primary objective is to determine whether pretreatment-to-posttreatment changes in circulating multigene methylation levels correlate with objective response rates (ORR) assessed by contrast-enhanced CT/MRI and levels of serum tumor markers. Secondary endpoints include: (a) time-dependent association between methylation fluctuation patterns and progression-free survival (PFS), (b) comparative diagnostic accuracy of methylation indices versus conventional biomarkers, and (c) feasibility of using methylation thresholds to guide adaptive therapy modification.

Вмешательства

  • Другое Multi-gene methylation testing
    Undergo multi-gene methylation testing in blood during follow-up
  • Другое Multi-gene methylation testing
    Undergo multi-gene methylation testing in blood during follow-up
  • Другое Multi-gene methylation testing
    Undergo multi-gene methylation testing in blood during follow-up
  • Другое Multi-gene methylation testing
    Undergo multi-gene methylation testing in blood during follow-up

Первичные конечные точки

  • Multi-gene methylation levels [Срок оценки: Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively.]
  • Multi-gene methylation levels [Срок оценки: Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
  • Multi-gene methylation levels [Срок оценки: Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
  • Multi-gene methylation levels [Срок оценки: Group four: pre-definitive chemoradiotherapy baseline, and post-definitive chemoradiotherapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
Вторичные конечные точки (12)
  • Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) [Срок оценки: Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively.]
  • Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) [Срок оценки: Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively.]
  • Endoscope [Срок оценки: Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively.]
  • Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) [Срок оценки: Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
  • Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) [Срок оценки: Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
  • Endoscope [Срок оценки: Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
  • Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) [Срок оценки: Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
  • Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) [Срок оценки: Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
  • Endoscope [Срок оценки: Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
  • Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) [Срок оценки: Group four: pre-definitive chemoradiotherapy baseline, and post-definitive chemoradiotherapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
  • Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) [Срок оценки: Group four: pre-definitive chemoradiotherapy baseline, and post-definitive chemoradiotherapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]
  • Endoscope [Срок оценки: Group four: pre-definitive chemoradiotherapy baseline, and post-definitive chemoradiotherapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.]

Критерии участия

Критерии включения

Age at initial diagnosis: 18-75 years (inclusive) Confirmed diagnosis: Histologically proven esophageal carcinoma with complete medical records, including (a) definitive pathological diagnosis report, (b) TNM staging per AJCC 8th edition criteria Cancer history: No prior malignancies at other anatomical sites (excluding cured non-melanoma skin cancers/carcinoma in situ) Metastasis status: Radiologically confirmed absence of distant metastases in liver, lungs, or other organs via contrast-enhanced CT/MRI and whole-body bone scan within 4 weeks before enrollment Treatment-naïve status: No previous exposure to (i) esophageal resection surgery, (ii) systemic chemotherapy, (iii) thoracic radiation therapy (>10 Gy), or (iv) PD-1/PD-L1 immune checkpoint inhibitors

Критерии исключения

Life expectancy <6 months (as assessed by ECOG score ≥4 or Palliative Performance Scale ≤30%) Cognitive/psychiatric conditions: a. Legally incapacitated individuals without legal guardians, b. Active psychotic disorders (e.g., schizophrenia, bipolar disorder) or dementia (MMSE score <24) Investigator-determined exclusions

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 · 9 центров
  • Gansu Wuwei Cancer Hospital — Wuwei
  • Cancer Hospital Affiliated to Shantou University Medical College — Shantou
  • Zhaoqing Gaoyao District People's Hospital — Zhaoqing
  • Henan Cancer Hospital — Чжэнчжоу
  • Tangdu Hospital — Сиань
  • Xijing Hospital — Сиань
  • The First Affiliated Hospital of Yan'an University — Yan’an
  • The First Affiliated Hospital of Shanxi Medical University — Taiyuan
  • … и ещё 1 центр

Идентификаторы

NCT: NCT06979869 · KY20252117-F-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗