EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

Официальное название

Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers

Обзор

The discovery of cell-free circulating tumor DNA (crDNA) in blood and the maturation of technologies for ctDNA analysis have presented an attractive opportunity for minimally invasive "liquid biopsy" genomic diagnostics. The investigators plan to perform EUS-guided portal vein and hepatic vein aspiration in GI cancers patients. The aim of the current study is thus to examine the concentration of ctDNA in portal vein (EUS-guided PVA), hepatic vein (EUS-guided HVA) and peripheral blood to understand the first pass effect of the liver with gastrointestinal (GI) cancers, and the possibility of using ctDNA as a marker for preoperative staging, restaging after neoadjuvant chemotherapy, and monitoring for recurrence.

Подробное описание

The discovery of cell-free circulating tumor DNA (crDNA) in blood and the maturation of technologies for ctDNA analysis have presented an attractive opportunity for minimally invasive "liquid biopsy" genomic diagnostics. The investigators plan to perform EUS-guided portal vein and hepatic vein aspiration in GI cancers patients. The aim of the current study is thus to examine the concentration of ctDNA in portal vein (EUS-guided PVA), hepatic vein (EUS-guided HVA) and peripheral blood to understand the first pass effect of the liver with gastrointestinal (GI) cancers, and the possibility of using ctDNA as a marker for preoperative staging, restaging after neoadjuvant chemotherapy, and monitoring for recurrence.

Вмешательства

• Диагностический тест EUS-guided portal vein and hepatic vein aspiration
  EUS-guided portal vein and hepatic vein aspiration

Первичные конечные точки

• Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood [Срок оценки: 3 months]

Вторичные конечные точки (7)

• Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA [Срок оценки: 3 months]
• Staging of the GI cancer [Срок оценки: 3 months]
• Recurrence [Срок оценки: 5 years]
• Overall survival [Срок оценки: 5 years]
• Progression-free survival [Срок оценки: 5 years]
• Technical success rate of EUS-PVA and HVA [Срок оценки: 1 day]
• Adverse events of EUS-PVA and HVA [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Age >= 18 years old
• Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer
• Undergoing treatment with either:

• Surgery
• Neoadjuvant chemotherapy
• Neoadjuvant chemoirradiation
• Palliative chemotherapy/ immunotherapy

Критерии исключения

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• Synchronous cancer of other sites
• Cardia, high lesser curve tumors, oesophagogastric junction tumors
• Presence of bulky lymph nodes at lesser curve/ coeliac region precluding a clear EUS puncture site to portal vein and hepatic vein
• Patients with coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL
• Patients unwilling to undergo follow-up assessments
• Patients with liver cirrhosis, portal hypertension and/ or gastric varices
• Patient refusal to participate

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Гонконг · 1 центр

• The Chinese University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT04782557 · 2020.321

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗