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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01709539
First received: October 12, 2012
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Cancer
Procedure: Diagnostiskt Centrum

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Time from first contact with primary care to information on diagnosis [ Time Frame: After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 37 days) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time from first contact with primary care to decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital [ Time Frame: After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be 10-15 days) ] [ Designated as safety issue: No ]
  • Time from decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital to information on diagnosis [ Time Frame: After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 22 days) ] [ Designated as safety issue: No ]
  • Survival after diagnosis of cancer or another serious disease [ Time Frame: For up to 10 years after diagnosis ] [ Designated as safety issue: No ]
  • Sick leave [ Time Frame: During the diagnosis process and for 24 months after diagnosis ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: During the diagnosis process and for 24 months after diagnosis ] [ Designated as safety issue: No ]
  • Overall medication use [ Time Frame: During the diagnosis process and for 24 months after diagnosis ] [ Designated as safety issue: No ]
  • Use of analgesics, antidepressants, and other psychotropic drugs [ Time Frame: During the diagnosis process and for 24 months after diagnosis ] [ Designated as safety issue: No ]
  • Time from information on diagnosis to decision about treatment [ Time Frame: From information on diagnosis to decision about treatment (anticipated to be up to 2 months) ] [ Designated as safety issue: No ]
  • Time from information on diagnosis to initiation of treatment [ Time Frame: From information on diagnosis to decision about treatment (anticipated to be up to 3 months) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Serum inflammatory biomarker levels [ Time Frame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care) ] [ Designated as safety issue: No ]
    Serum inflammatory cytokine levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).

  • Serum epidermal growth factor (EGF) receptor levels [ Time Frame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care) ] [ Designated as safety issue: No ]
    Serum EGF receptor levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).

  • Plasma microRNA levels [ Time Frame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care) ] [ Designated as safety issue: No ]
    Plasma microRNA levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).

  • Telomere length [ Time Frame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 1725
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709539

Contacts
Contact: Jan Sundquist, MD, PhD +4640391378 jan.sundquist@med.lu.se
Contact: Emelie Stenman, PhD +4640391380 emelie.stenman@med.lu.se

Locations
Sweden
Helsingborg General Hospital Not yet recruiting
Helsingborg, Skåne, Sweden, 251 87
Diagnostiskt Centrum, Kristianstad General Hospital Recruiting
Kristianstad, Skåne, Sweden, 291 85
Principal Investigator: Stefan Rydén, MD, PhD         
Sub-Investigator: Inga Svensson         
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Jan Sundquist, MD, PhD Center for Primary Health Care Research, Malmö, Sweden
  More Information

Additional Information:
No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01709539     History of Changes
Other Study ID Numbers: CPF-DC
Study First Received: October 12, 2012
Last Updated: April 24, 2013
Health Authority: Sweden: Swedish Data Inspection Board

Keywords provided by Region Skane:
Cancer diagnosis center
Time to diagnosis
Survival
Health economics
Biomarkers

ClinicalTrials.gov processed this record on November 24, 2014