MEDECA - Markers in Early Detection of Cancer

Cancer Clinical Trial

— MEDECA  

Official title:

MEDECA - Markers in Early Detection of Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06355245
• Other study ID #: 2017/2160-31/1
• Status: Recruiting
• Start date: March 1, 2018
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Danderyd Hospital
• Contact: Charlotte Thålin, M.D., Ph.D.
• Phone: +46709565120
• Email: charlotte.thalin[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Diagnosis

Intervention

Diagnostic Test:
• Blood sampling
Collection of blood samples

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer diagnosis	Patients undergo an extensive diagnostic work-up and diagnoses are obtained from medical records	During diagnostic work-up (within six months)
Secondary	Other diagnosis	Patients undergo an extensive diagnostic work-up and diagnoses are obtained from medical records	During the diagnostic work-up (within six months) as well as in a one-year follow-up
Secondary	Mortality	Will be obtained from medical records	Within 1 year from inclusion
Secondary	Cancer diagnosis	Will be obtained from medical records	Within 1 year from inclusion