MEDECA - Markers in Early Detection of Cancer

Recruiting

• Conditions: Diagnosis; Cancer
• Interventions: Diagnostic Test: Blood sampling

• Registration Number: NCT06355245
• Lead Sponsor: Danderyd Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2024-01-10
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with unspecific symptoms	Blood sampling	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.

Primary Outcome Measures

Name	Time	Method
Cancer diagnosis	During diagnostic work-up (within six months)	Patients undergo an extensive diagnostic work-up and diagnoses are obtained from medical records

Secondary Outcome Measures

Name	Time	Method
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
Cancer diagnosis	Within 1 year from inclusion	Will be obtained from medical records
Mortality	Within 1 year from inclusion	Will be obtained from medical records

Trial Locations

Locations (1)

Danderyd Hospital; 🇸🇪 Stockholm, Sweden