Skip to main content
Clinical Trials/NCT06355245
NCT06355245RecruitingNot Applicable

MEDECA - Markers in Early Detection of Cancer

Danderyd Hospital1 site in 1 country1,500 target enrollmentStarted: March 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
1,500
Locations
1
Primary Endpoint
Cancer diagnosis

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Cancer diagnosis

Time Frame: During diagnostic work-up (within six months)

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

Secondary Outcomes

  • Other diagnosis(During the diagnostic work-up (within six months) as well as in a one-year follow-up)
  • Cancer diagnosis(Within 1 year from inclusion)
  • Mortality(Within 1 year from inclusion)

Investigators

Sponsor
Danderyd Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Charlotte Thålin

M.D., Ph.D. Senior consultant in internal medicine

Danderyd Hospital

Study Sites (1)

Loading locations...

Similar Trials