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临床试验/NCT06305169
NCT06305169尚未招募不适用

Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer Along With Creating a Predictive Model for the Identification of Patients That Need Urgent Endoscopy

Sandwell & West Birmingham Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
440
试验地点
1
主要终点
Measurement of the specificity and negative predictive value of serum biomarkers in gastric cancer

研究概览

简要总结

Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis.

The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad.

To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy.

A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred for a 2 week wait cancer pathway endoscopy for the following indications Or Upper abdominal mass consistent with stomach cancer Or Stable upper gastrointestinal bleeding Or
  • Aged 55 and over with weight loss and any of the following:
  • Upper abdominal pain
  • Dyspepsia

排除标准

  • Referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion)
  • Previous gastro-duodenal surgery,
  • Any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease)

结局指标

主要结局

Measurement of the specificity and negative predictive value of serum biomarkers in gastric cancer

时间窗: 12 months

Gastric serum biomarkers measured by gastropanel will be measured in 400 patients who undergo endoscopy. The research team will measure the specificity and negative predictive value of gastropanel in excluding gastric cancer in patient enrolled into the study.

次要结局

  • Creating a scoring system for patients that warrant urgent endoscopy on the cancer pathway(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nigel Trudgill

Consultant Gastroenterologist

Sandwell & West Birmingham Hospitals NHS Trust

研究点 (1)

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