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Идёт набор NCT04743102

Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer

Без фазы С лечением Rectal Cancer Neoadjuvant Therapy Complete Remission Metastasis

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-points and full-thickness Biopsy, traditional cCR.
Кому может быть актуально
Состояния в реестре: Rectal Cancer, Neoadjuvant Therapy, Complete Remission, Metastasis. Базовые параметры: 18 лет — 80 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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Официальное название

Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer

Обзор

Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. As a result, clinical complete response (cCR), defined as no clinical detectable tumor by physical examination, endoscopic evaluation, and imaging, is designed as a surrogate endpoint for pCR. However, the concordance between cCR and pCR varies from 22% to 96% in different reports, which questions the clinical value of such strategies. Therefore, based on rectal diginal examination, serum CEA, MRI, endoscopy examination, we suggested to add multi-points and full-thickness biopsy technique to further improve the accuracy of cCR.

Вмешательства

  • Процедура multi-points and full-thickness Biopsy
    Four points around the tumor site and center of the tumor site full-thickness Biopsy
  • Диагностический тест traditional cCR
    diginal examination, endoscopy test, rectal MRI, and serum CEA level

Первичные конечные точки

  • Clinical Complete Response rate [Срок оценки: 8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer]
  • pathological complete remission [Срок оценки: 2 weeks after patients received radical operation]
Вторичные конечные точки (2)
  • Disease Free Survival [Срок оценки: 5 years after operation or "watch and wait" approach]
  • Overall Survival [Срок оценки: 5 years after operation or "watch and wait" approach]

Критерии участия

Критерии включения

  • Adult male and female, between 18 and 80 years old;
  • Colonoscopy biopsy pathology confirmed colorectal adenocarcinoma;
  • The distance from the lower margin of the tumor to the anal margin ≤12 cm (endoscope) or to the anorectal ring ≤8 cm;
  • The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia;
  • Initial local MRI stage was T2 or T3A or T3B, N0-2, negative for extramural vascular invasion (EMVI), circumferential ential resection margin (CRM), and no peripheral iliac, common iliac, obturator, or abdominal aortic lymph node metastasis;
  • CCR patients evaluated after neoadjuvant therapy (no mass or ulcer found on digital rectal examination;Endoscopic examination showed no other changes except flat scar, telangiectasia or pallor of mucosa.MRI or rectal ultrasound showed no residual tumor in the primary site and lymphatic drainage area.Serum carcinoembryonic antigen (CEA) was normal.
  • Signing informed consent for surgery.

Критерии исключения

  • Previous history of malignant colorectal tumor;
  • Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery;
  • Unresectable lymph node metastasis;
  • Recently diagnosed with other malignant tumors;
  • Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment;
  • ASA rating ≥IV and/or ECOG physical status score ≥2 points;
  • Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases cannot tolerate surgery;
  • a history of serious mental illness;

\- pregnant or lactating women;

  • Those with uncontrolled infection;
  • Patients with other clinical or laboratory conditions considered by the investigator should not participate in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Beijing Chaoyang Hospital — Пекин

Идентификаторы

NCT: NCT04743102 · BIOPSY-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗