MEDECA - Markers in Early Detection of Cancer

NCT06355245 | Recruiting

• 1 other identifier: 2017/2160-31/1
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Cancer diagnosis

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

  During diagnostic work-up (within six months)

Secondary Outcomes (3)

• Other diagnosis

  During the diagnostic work-up (within six months) as well as in a one-year follow-up

• Mortality

  Within 1 year from inclusion

• Cancer diagnosis

  Within 1 year from inclusion

Study Arms (1)

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

Blood sampling DIAGNOSTIC_TEST

Collection of blood samples

Patients with unspecific symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Danderyd Hospital: lead

Study Sites (1)

Danderyd Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Neoplasms; Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Charlotte Thålin, M.D., Ph.D

  Danderyd Hospital Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Thålin, M.D., Ph.D.

CONTACT

+46709565120; charlotte.thalin@regionstockholm.se

Nina Greilert Norin, RN

CONTACT

+465660243; nina.greilert@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D. Senior consultant in internal medicine

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: April 9, 2024
• Study Start: March 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)