MEDECA - Markers in Early Detection of Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling.
- Who it may be relevant to
- Registry conditions: Cancer, Diagnosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test Blood sampling
Collection of blood samples
Primary outcome measures
- Cancer diagnosis [Time frame: During diagnostic work-up (within six months)]
Secondary outcome measures (3)
- Other diagnosis [Time frame: During the diagnostic work-up (within six months) as well as in a one-year follow-up]
- Mortality [Time frame: Within 1 year from inclusion]
- Cancer diagnosis [Time frame: Within 1 year from inclusion]
Eligibility criteria
Inclusion criteria
\- 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
Exclusion criteria
- Unwillingness to participate in the study
- Age below 18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Danderyd Hospital — Stockholm
Identifiers
NCT: NCT06355245 · 2017/2160-31/1