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RecruitingNCT06355245MEDECAUpdated Apr 9, 2024

MEDECA - Markers in Early Detection of Cancer

An observational study in Cancer and Diagnosis, sponsored by Danderyd Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Danderyd Hospital · Observational

From the registry’s dates

  • Started Mar 2018; still recruiting 8 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer
  • Diagnosis
03

In context

Lead sponsor

Danderyd Hospital is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Unwillingness to participate in the study
  • Age below 18 years
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with unspecific symptoms

    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.

    Diagnostic Test: Blood sampling

Interventions

  • Diagnostic testBlood sampling

    Collection of blood samples

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06355245
Lead sponsor
Danderyd Hospital
Responsible party
Charlotte Thålin (M.D., Ph.D. Senior consultant in internal medicine, Danderyd Hospital) — Principal investigator
First posted
Apr 9, 2024
Start date
Mar 1, 2018
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 9, 2024

Study contacts

Charlotte Thålin, M.D., Ph.D.
Contact
charlotte.thalin@regionstockholm.se
+46709565120
Nina Greilert Norin, RN
Contact
nina.greilert@ki.se
+465660243
Charlotte Thålin, M.D., Ph.D
principal investigator · Danderyd Hospital Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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