Меню
Идёт набор NCT06321939

Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma

— Наблюдательное Nasopharyngeal Carcinoma Herpesvirus 4, Human

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: EBV-DNA next generation sequencing.
Кому может быть актуально
Состояния в реестре: Nasopharyngeal Carcinoma, Herpesvirus 4, Human. 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 investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future.

Подробное описание

The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future.

Вмешательства

  • Диагностический тест EBV-DNA next generation sequencing
    EBV-DNA next generation sequencing

Первичные конечные точки

  • Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing [Срок оценки: from diagnose to 4-8 weeks after definitive radiotherapy]
Вторичные конечные точки (6)
  • Overall survival [Срок оценки: 2 year]
  • Distant metastasis failure-free survival [Срок оценки: 2 year]
  • Locoregional failure-free survival [Срок оценки: 2 year]
  • Failure-free survival [Срок оценки: 2 year]
  • Patient reported quality-of-life score [Срок оценки: up to 2 years]
  • Biomarker analysis [Срок оценки: from diagnose to 4-8 weeks after definitive radiotherapy]

Критерии участия

Критерии включения

  • Newly diagnosed, pathologically proven World Health Organization (WHO) type II/III untreated NPC;
  • Non-metastatic NPC (I-IVA, according to the 8th edition of the AJCC/UICC clinical staging system);
  • Age at diagnosis: over 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) score: 0-1
  • Receiving recommended curative intention treatments：definitive radiotherapy w/wo three cycles of induction chemotherapy (IC) (gemcitabine-cisplatin \[GP\] or paclitaxel-cisplatin \[TP\] regimen);
  • Pre-treatment and post-IC1 cell-free Epstein-Barr virus (cfEBV) DNA > 0 copy/mL; systemic cfEBV DNA monitoring during IC phase for risk stratification;
  • Normal hematic, liver, and kidney function: hemoglobin (HG) > 90 g/L; neutrophil > 1.5 × 109/L; platelet > 100 × 109/L; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; creatinine clearance (Ccr) ≥ 60 mL/min;
  • Female subjects capable of becoming pregnant agree to use reliable contraceptive measures from screening to 1 year after treatment;
  • Patients will be required to sign informed consent forms and be willing and able to comply with the requirements for visits, treatment, laboratory tests, and other research requirements stipulated in the research schedule.

Критерии исключения

  • Receiving surgery, target therapy, and/or immunotherapy during or before induction phase;
  • Other previous or concurrent malignant tumors, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary cancer;
  • Pregnant or lactating women (a pregnancy test should be considered for fertile women with an active sex life);
  • Previously treated with radical radiotherapy (RT), except non-melanoma skin cancers outside intended RT treatment volume;
  • Uncontrolled heart disease, e.g.: 1) Heart failure, New York Heart Association (NYHA) level ≥ 2; 2) unstable angina; 3) myocardial infarction in the past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention.

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
  • Hunan cancer Hospital — Чанша

Идентификаторы

NCT: NCT06321939 · NPCNS 001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗