About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
General malaise
Severe tiredness
Unintentional weight loss
Fever of unknown cause
Disqualifiers
Unwillingness to participate in the study
Age below 18 years
Trial population
Study participants are enrolled at the first visit to DC DS. The criteria for referral to DC DS are radiological findings suggestive of metastasis without known primary tumor or suspicion of serious illness based on one or more of the following symptoms: 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, marked increase in drug usage or increasing health service seeking behavior.
Trial design
Cohort
Prospective
Treatments tested in this trial
Blood sampling
Diagnostic testCollection of blood samples
Treatment groups
Trial outcomes
Primary outcomes
Cancer diagnosis
Patients undergo an extensive diagnostic work-up and diagnoses are obtained from medical records
Secondary outcomes
Other diagnosis
Patients undergo an extensive diagnostic work-up and diagnoses are obtained from medical records
Mortality
Will be obtained from medical records
Cancer diagnosis
Will be obtained from medical records
Sponsors and contacts
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