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临床试验/NCT06355245
NCT06355245招募中不适用

MEDECA - Markers in Early Detection of Cancer

Danderyd Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Cancer diagnosis

研究概览

简要总结

Early diagnosis of cancer is key for improving patient outcomes, but cancers are difficult to diagnose if patients present with unspecific symptoms. The principal objective of the MEDECA (Markers in Early Detection of Cancer) study is to identify a multi-analyte blood test that can detect and map occult cancer within a mixed population of patients presenting with serious but unspecific symptoms. The study will include 1500 patients referred to the Diagnostic Center at Danderyd Hospital (DC DS), a multidisciplinary diagnostic center referral pathway for patients with radiological findings suggestive of metastasis without known primary tumor or suspicion of serious but unspecific symptoms. Blood samples are collected prior to a standardized and extensive cancer diagnostic work-up, including an expanded panel of biochemical analyses and extensive imaging such as computed tomography or magnetic resonance investigations. In collaboration with world-leading international scientists, the blood samples will be analyzed for a panel of novel and established blood biomarkers predictive of an underlying cancer, including markers of neutrophil extracellular traps, circulating tumor DNA, platelet mRNA profiling, affinity-based proteomics and nuclear magnetic resonance metabolomics. The diagnostic accuracy of the blood biomarkers with respect to cancer detection during the diagnostic work-up will be analyzed through machine learning.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 18 years
  • One or more of the following symptoms/clinical signs:
  • General malaise
  • Severe tiredness
  • Unintentional weight loss
  • Fever of unknown cause
  • Uncharacteristic pain for >4 weeks
  • Abnormal laboratory tests (e.g., anemia, elevated alkaline phosphatase levels, erythrocyte sedimentation rate (ESR), calcium etc.)
  • Diffuse pain without explanation
  • Marked increase in drug usage
  • Increasing health service seeking behavior
  • Radiological findings suggestive of metastasis without known primary tumor or suspicion

排除标准

  • Unwillingness to participate in the study
  • Age below 18 years

结局指标

主要结局

Cancer diagnosis

时间窗: During diagnostic work-up (within six months)

Patients undergo an extensive diagnostic work-up and diagnoses are obtained from medical records

次要结局

  • Other diagnosis(During the diagnostic work-up (within six months) as well as in a one-year follow-up)
  • Cancer diagnosis(Within 1 year from inclusion)
  • Mortality(Within 1 year from inclusion)

研究者

发起方
Danderyd Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotte Thålin

M.D., Ph.D. Senior consultant in internal medicine

Danderyd Hospital

研究点 (1)

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