Меню
Набор скоро начнётся NCT06941987

Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer

— Наблюдательное Minimal Residual Disease Pancreatic Cancer Resectable

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: Minimal Residual Disease, Pancreatic Cancer Resectable. 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
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 →

Обзор

The goal of this observational study is to learn about the diagnostic performance of a novel Neoantigen-Reactive CD8+ T cell (NART) technology detecting minimal residual disease (MRD) in postoperative surveillance of pancreatic cancer. The main question it aims to answer is: Is NART a sensitive and accurate detection for MRD? Participants are required to undergo periodic blood sampling and imaging examinations as the protocol specifies.

Первичные конечные точки

  • The correlation between NART detection and recurrence-free survival [Срок оценки: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months]
Вторичные конечные точки (8)
  • The correlation between conventional ct-DNA test and RFS [Срок оценки: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months]
  • The correlation between serum markers and RFS [Срок оценки: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months]
  • The correlation between NART detection and overall survival (OS) [Срок оценки: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months]
  • The correlation between conventional ct-DNA test and OS [Срок оценки: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months]
  • The correlation between serum markers and OS [Срок оценки: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months]
  • The diagnostic performance of NART detection [Срок оценки: From the date of first enrollment until the study completion, an average of 30 months.]
  • The diagnostic performance of conventional ct-DNA test. [Срок оценки: From the date of first enrollment until the study completion, an average of 30 months.]
  • The diagnostic performance of serum markers. [Срок оценки: From the date of first enrollment until the study completion, an average of 30 months.]

Критерии участия

Критерии включения

  • age >18
  • Assessd as resectable PDAC before surgical procedure
  • Voluntary to donate tumor samples resected in curative surgery for PDAC
  • Voluntary to participate in the radiological evaluation, tests of serum tumor markers, and the collection of MRD samples according to the study protocol
  • ECOG state (PS) grades ≤ 2
  • Voluntary to sign informed consent and adhering to the requirements and limitations outlined by lCD and this protocol
  • Confimed as pancreatic ductal adenocarcinoma by pathology
  • RO or R1 resection
  • Clinically evalutated eligible for adjuvant therapy
  • Tumor tissue samples meet the requirements of whole exome sequencing (WES)

Критерии исключения

  • Preoperative imaging examinations show distant metastasis
  • Have received neoadjuvant therapy
  • Have any other active malignancy within 5 years before enrollment, or have any other indolent cancers that did not interfere with the primary cancer assessment in the study without prior approval from the research committee
  • With other physical or mental conditions that may increase the risk of study participation or (in the investigator's judgment) may make the subject ineligible for study participation, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormalities
  • Have participated in other interventional or observational clinical studies

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 · 1 центр
  • Zhongshan Hospital, Shanghai — Шанхай

Идентификаторы

NCT: NCT06941987 · ZSPAC-11

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗