MEDECA - Markers in Early Detection of Cancer (MEDECA)

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 Overview

• Status: Recruiting
• Conditions: Cancer; Diagnosis
• Intervention / Treatment: Diagnostic test: Blood sampling

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Charlotte Thålin, M.D., Ph.D.; Phone Number: +46709565120; Email: charlotte.thalin@regionstockholm.se
• Study Contact Backup: Name: Nina Greilert Norin, RN; Phone Number: +465660243; Email: nina.greilert@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Danderyd Hospital
    • Contact: Charlotte Thålin, M.D., Ph.D.; Phone Number: +46709565120; Email: charlotte.thalin@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Collection of blood samples

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mortality	Will be obtained from medical records	Within 1 year from inclusion
Cancer diagnosis	Will be obtained from medical records	Within 1 year from inclusion

Collaborators and Investigators

• Sponsor: Danderyd Hospital
• Investigators: Principal Investigator: Charlotte Thålin, M.D., Ph.D, Danderyd Hospital Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2017/2160-31/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No