MEDECA - Markers in Early Detection of Cancer

ConditionsCancerDiagnosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDanderyd Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling

    Diagnostic test

    Collection of blood samples

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Patients with unspecific symptoms1 intervention

Trial outcomes

Primary outcomes

1

Cancer diagnosis

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

Time frame
During diagnostic work-up (within six months)

Secondary outcomes

1

Other diagnosis

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

Time frame
During the diagnostic work-up (within six months) as well as in a one-year follow-up
2

Mortality

Will be obtained from medical records

Time frame
Within 1 year from inclusion
3

Cancer diagnosis

Will be obtained from medical records

Time frame
Within 1 year from inclusion

Other outcomes

Sponsors and contacts

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