Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden (CPF-DC)

The aim of this study is to evaluate a new cancer diagnosis center (Diagnostiskt Centrum, DC) in Kristianstad, Sweden. Patients aged ≥ 18 years who are suspected of having serious illness but who have no organ-specific symptoms will be referred to the DC for further investigation after preliminary assessment in primary care. The overall purpose of the study is to evaluate whether the DC meets its target time for diagnosing cancer. In addition, we will evaluate secondary issues, such as survival, to determine whether this pilot project merits extension to other parts of southern Sweden.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Procedure: Diagnostiskt Centrum

Detailed Description

Diagnostiskt Centrum (DC), Sweden's first specialized cancer diagnosis center, was established at Kristianstad General Hospital in 2012 as a model for reducing the time taken to diagnose cancer in primary care patients with diffuse, non-organ specific symptoms. If it is successful, the DC model could be rolled out to other areas of Sweden. This study by the Center for Primary Health Care Research in Malmö, Sweden and Regionalt cancercentrum syd will investigate whether the DC process reduces the time from (1) the point when the patient first contacts his/her primary care center with symptoms to (2) the point when he/she is informed about his/her diagnosis (of cancer or another disease). This will be achieved by comparison with matched control patients with suspected cancer who will be referred to Helsingborg General Hospital for further investigation according to existing diagnostic procedures. Various outcome measures will be investigated, and patients' experiences of the DC process will be assessed using a tailored questionnaire. In addition, the DC model will be subjected to health economics analysis.

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Helsingborg, Skåne, Sweden, 251 87
      • Helsingborg General Hospital
    • Kristianstad, Skåne, Sweden, 291 85
      • Diagnostiskt Centrum, Kristianstad General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Individuals in two cities in southern Sweden (Helsingborg and Kristianstad) who contact their primary care center because of diffuse, non-organ-specific symptoms

Inclusion criteria: suspicion of cancer following preliminary investigation in primary care

Exclusion criteria: (1) age < 18 years; and (2) inability to fill in the patient questionnaire

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostiskt Centrum; Investigation at the primary care center followed by further investigation at Diagnostiskt Centrum, Kristianstad General Hospital	Procedure: Diagnostiskt Centrum; Patients who are suspected of having cancer after investigation at the primary care center will be referred to Diagnostiskt Centrum. Each patient who is referred to Diagnostiskt Centrum will undergo the following: (1) clinical chemistry/microbiology tests; (2) medical history; (3) objective clinical examination; and (4) taking of blood samples for analysis of biomarkers. If necessary, patients will also undergo the following: (5) additional laboratory tests; (6) biopsy; (7) X-ray of painful joints; (8) CT scan of the neck, thorax, abdomen, and/or pelvis; (9) mammography and gynecological examination; (10); gastroscopy and/or colonoscopy; and (11) further investigation (e.g., PET-CT scan).; Other Names: Cancer diagnosis center, Kristianstad General Hospital
No Intervention: Existing diagnostic procedures; Investigation at the primary care center followed by further investigation at Helsingborg General Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from first contact with primary care to information on diagnosis	The time from the point at which the patient first makes contact with his/her primary care center to the point when he/she is given his/her diagnosis. This comprises two elements: (1) investigation in primary care and (2) investigation at Diagnostiskt Centrum/Helsingborg General Hospital. These two elements will be investigated as secondary outcome measures.	After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 37 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from first contact with primary care to decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital	After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be 10-15 days)
Time from decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital to information on diagnosis	After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 22 days)
Survival after diagnosis of cancer or another serious disease	For up to 10 years after diagnosis
Sick leave	During the diagnosis process and for 24 months after diagnosis
Health care utilization	During the diagnosis process and for 24 months after diagnosis
Overall medication use	During the diagnosis process and for 24 months after diagnosis
Use of analgesics, antidepressants, and other psychotropic drugs	During the diagnosis process and for 24 months after diagnosis
Time from information on diagnosis to decision about treatment	From information on diagnosis to decision about treatment (anticipated to be up to 2 months)
Time from information on diagnosis to initiation of treatment	From information on diagnosis to decision about treatment (anticipated to be up to 3 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum inflammatory biomarker levels	Serum inflammatory cytokine levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).	During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
Serum epidermal growth factor (EGF) receptor levels	Serum EGF receptor levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).	During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
Plasma microRNA levels	Plasma microRNA levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).	During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
Telomere length	Telomere length (measured using whole-blood samples) will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).	During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Jan Sundquist, MD, PhD, Center for Primary Health Care Research, Malmö, Sweden

Publications and helpful links

General Publications

• Sundquist J, Palmér K, Rydén S, Sävblom C, Ji J, Stenman E. Time Intervals Under the Lens at Sweden's First Diagnostic Center for Primary Care Patients With Nonspecific Symptoms of Cancer. A Comparison With Matched Control Patients. Front Oncol. 2020 Nov 30;10:561379. doi: 10.3389/fonc.2020.561379. eCollection 2020.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (Estimate): October 18, 2012

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Survival; Biomarkers; Cancer diagnosis center; Time to diagnosis; Health economics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: CPF-DC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No