Clinical trial NCT06355245: MEDECA - Markers in Early Detection of Cancer
Official title: MEDECA - Markers in Early Detection of Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Diagnosis
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.


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

Primary outcomes:
measure: Cancer diagnosis
timeFrame: During diagnostic work-up (within six months)
Secondary outcomes:
measure: Other diagnosis
timeFrame: During the diagnostic work-up (within six months) as well as in a one-year follow-up
measure: Mortality
timeFrame: Within 1 year from inclusion
measure: Cancer diagnosis
timeFrame: Within 1 year from inclusion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: Danderyd Hospital Karolinska Institutet
name: Charlotte Thålin, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: