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Recruiting

NCT Number: NCT06355245

MEDECA - Markers in Early Detection of Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danderyd Hospital

Stockholm, Sweden

Location status: Recruiting

Location contact

Charlotte Thålin, M.D., Ph.D.

CONTACT

[email protected]

+46709565120

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Diagnostic Test

Collection of blood samples

Primary outcomes

  1. 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

  1. Other diagnosis

    Time frame: 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

  2. Mortality

    Time frame: Within 1 year from inclusion

    Will be obtained from medical records

  3. Cancer diagnosis

    Time frame: Within 1 year from inclusion

    Will be obtained from medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Thålin, M.D., Ph.D.

CONTACT

[email protected]

+46709565120

Nina Greilert Norin, RN

CONTACT

[email protected]

+465660243

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Acronym: MEDECA

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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