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Набор по приглашению NCT07241676

Early Recurrence After Surgery for Pancreatic Cancer

— Наблюдательное Pancreatic Ductal Adenocarcinoma (PDAC) Recurrent Pancreatic Adenocarcinoma

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: Curative-intent resection (R0, R1).
Кому может быть актуально
Состояния в реестре: Pancreatic Ductal Adenocarcinoma (PDAC), Recurrent Pancreatic Adenocarcinoma. 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
Италия
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

Early Recurrence and Futility After Curative-intent Resection of Pancreatic Ductal Adenocarcinoma

Обзор

The goal of this observational study is to learn about early recurrence after curative-intent surgery for pancreatic cancer. The main questions it aims to answer are: * How often does early recurrence (within 12 months after surgery) occur? * When does it happen, and at which anatomical sites (liver, lung, local, peritoneum)? * How is recurrence detected (imaging or tumor markers)? Adults with histologically confirmed pancreatic ductal adenocarcinoma who undergo curative-intent resection without distant metastases will be enrolled. Participants will be followed according to routine clinical care at each hospital, typically with imaging and CA19-9 blood tests. No study-specific interventions are required.

Подробное описание

This international, prospective, multicenter observational study aims to characterize early recurrence (ER) after curative-intent resection of pancreatic ductal adenocarcinoma (PDAC). ER is defined as recurrence occurring within 12 months following surgery.

The study will assess the incidence, timing, anatomical sites, and detection mode (radiologic vs. biochemical) of ER, as well as post-recurrence treatment patterns and short-term outcomes. Secondary aims include comparison between neoadjuvant and upfront surgery cohorts, evaluation of biochemical-only recurrence, and identification of clinical or pathological factors predictive of ER.

Consecutive eligible patients will be enrolled from high-volume pancreatic surgery centers worldwide and followed according to institutional standards of care, typically involving routine imaging and CA19-9 surveillance. Standardized data will be prospectively collected to describe recurrence patterns and post-recurrence management. No study-specific interventions are required.

Вмешательства

  • Процедура Curative-intent resection (R0, R1)
    Standard-of-care surgical resection for pancreatic ductal adenocarcinoma, as determined by the multidisciplinary team. No study-specific interventions are mandated.

Первичные конечные точки

  • Incidence, timing, mode of detection, and anatomical site of early recurrence [Срок оценки: Within 12 months post-surgery]
Вторичные конечные точки (5)
  • Comparison of ER patterns in patients treated with neoadjuvant therapy versus upfront surgery [Срок оценки: 12 months post-surgery]
  • Incidence and clinical impact of biochemical-only recurrence [Срок оценки: 12 months post-surgery]
  • Post-recurrence treatment strategies and short-term survival outcomes [Срок оценки: From recurrence up to 24 months post-surgery]
  • Clinical and pathological predictors of early recurrence [Срок оценки: Up to 12 months post-surgery]
  • Validation of futility criteria for upfront surgery patients [Срок оценки: Within 6 months post-surgery]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Histologically confirmed pancreatic ductal adenocarcinoma (PDAC)
  • Undergoing curative-intent resection (R0 or R1)
  • No evidence of distant metastasis at the time of surgery
  • Availability of preoperative CA19-9 value and pancreas-protocol CT or MRI
  • Ability to provide written informed consent

Критерии исключения

  • Withdrawal of informed consent
  • Pathological diagnosis other than PDAC (e.g., neuroendocrine tumor, acinar cell carcinoma, invasive IPMN)
  • Surgery performed for palliative or diagnostic purposes only
  • Intraoperative discovery of unresectable disease or distant metastases
  • Gross residual disease (R2 resection)
  • Incomplete clinical or radiologic follow-up precluding recurrence assessment
  • Absence of adequate preoperative contrast-enhanced pancreas-protocol CT or MRI preventing accurate staging and metastatic evaluation
  • Interval >9 months between two consecutive follow-up visits
  • Major protocol deviations or insufficient data, as judged by the site investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • University of Padova — Padova

Идентификаторы

NCT: NCT07241676 · AOP3909

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗