Cancer, Diagnosis
Conditions
Brief summary
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_TESTBlood sampling
Collection of blood samples
Sponsors
Danderyd Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer diagnosis | During diagnostic work-up (within six months) | Patients undergo an extensive diagnostic work-up and diagnoses are obtained from medical records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other diagnosis | During the diagnostic work-up (within six months) as well as in a one-year follow-up | Patients undergo an extensive diagnostic work-up and diagnoses are obtained from medical records |
| Mortality | Within 1 year from inclusion | Will be obtained from medical records |
| Cancer diagnosis | Within 1 year from inclusion | Will be obtained from medical records |
Countries
Sweden
Contacts
Primary ContactCharlotte Thålin, M.D., Ph.D.
Backup ContactNina Greilert Norin, RN
Outcome results
None listed