<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01709539</url>
  </required_header>
  <id_info>
    <org_study_id>CPF-DC</org_study_id>
    <nct_id>NCT01709539</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden</brief_title>
  <acronym>CPF-DC</acronym>
  <official_title>Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate a new cancer diagnosis center (Diagnostiskt Centrum, DC)&#xD;
      in Kristianstad, Sweden. Patients aged ≥ 18 years who are suspected of having serious illness&#xD;
      but who have no organ-specific symptoms will be referred to the DC for further investigation&#xD;
      after preliminary assessment in primary care. The overall purpose of the study is to evaluate&#xD;
      whether the DC meets its target time for diagnosing cancer. In addition, we will evaluate&#xD;
      secondary issues, such as survival, to determine whether this pilot project merits extension&#xD;
      to other parts of southern Sweden.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diagnostiskt Centrum (DC), Sweden's first specialized cancer diagnosis center, was&#xD;
      established at Kristianstad General Hospital in 2012 as a model for reducing the time taken&#xD;
      to diagnose cancer in primary care patients with diffuse, non-organ specific symptoms. If it&#xD;
      is successful, the DC model could be rolled out to other areas of Sweden. This study by the&#xD;
      Center for Primary Health Care Research in Malmö, Sweden and Regionalt cancercentrum syd will&#xD;
      investigate whether the DC process reduces the time from (1) the point when the patient first&#xD;
      contacts his/her primary care center with symptoms to (2) the point when he/she is informed&#xD;
      about his/her diagnosis (of cancer or another disease). This will be achieved by comparison&#xD;
      with matched control patients with suspected cancer who will be referred to Helsingborg&#xD;
      General Hospital for further investigation according to existing diagnostic procedures.&#xD;
      Various outcome measures will be investigated, and patients' experiences of the DC process&#xD;
      will be assessed using a tailored questionnaire. In addition, the DC model will be subjected&#xD;
      to health economics analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">June 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time from first contact with primary care to information on diagnosis</measure>
    <time_frame>After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 37 days)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from first contact with primary care to decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital</measure>
    <time_frame>After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be 10-15 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital to information on diagnosis</measure>
    <time_frame>After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 22 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival after diagnosis of cancer or another serious disease</measure>
    <time_frame>For up to 10 years after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sick leave</measure>
    <time_frame>During the diagnosis process and for 24 months after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>During the diagnosis process and for 24 months after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall medication use</measure>
    <time_frame>During the diagnosis process and for 24 months after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of analgesics, antidepressants, and other psychotropic drugs</measure>
    <time_frame>During the diagnosis process and for 24 months after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from information on diagnosis to decision about treatment</measure>
    <time_frame>From information on diagnosis to decision about treatment (anticipated to be up to 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from information on diagnosis to initiation of treatment</measure>
    <time_frame>From information on diagnosis to decision about treatment (anticipated to be up to 3 months)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum inflammatory biomarker levels</measure>
    <time_frame>During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)</time_frame>
    <description>Serum inflammatory cytokine levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum epidermal growth factor (EGF) receptor levels</measure>
    <time_frame>During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)</time_frame>
    <description>Serum EGF receptor levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma microRNA levels</measure>
    <time_frame>During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)</time_frame>
    <description>Plasma microRNA levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).</description>
  </other_outcome>
  <other_outcome>
    <measure>Telomere length</measure>
    <time_frame>During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)</time_frame>
    <description>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).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">388</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Diagnostiskt Centrum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Investigation at the primary care center followed by further investigation at Diagnostiskt Centrum, Kristianstad General Hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Existing diagnostic procedures</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Investigation at the primary care center followed by further investigation at Helsingborg General Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diagnostiskt Centrum</intervention_name>
    <description>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).</description>
    <arm_group_label>Diagnostiskt Centrum</arm_group_label>
    <other_name>Cancer diagnosis center, Kristianstad General Hospital</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Individuals in two cities in southern Sweden (Helsingborg and Kristianstad) who contact&#xD;
        their primary care center because of diffuse, non-organ-specific symptoms&#xD;
&#xD;
        Inclusion criteria: suspicion of cancer following preliminary investigation in primary care&#xD;
&#xD;
        Exclusion criteria: (1) age &lt; 18 years; and (2) inability to fill in the patient&#xD;
        questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Sundquist, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Primary Health Care Research, Malmö, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helsingborg General Hospital</name>
      <address>
        <city>Helsingborg</city>
        <state>Skåne</state>
        <zip>251 87</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostiskt Centrum, Kristianstad General Hospital</name>
      <address>
        <city>Kristianstad</city>
        <state>Skåne</state>
        <zip>291 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer diagnosis center</keyword>
  <keyword>Time to diagnosis</keyword>
  <keyword>Survival</keyword>
  <keyword>Health economics</keyword>
  <keyword>Biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01709539
org study id: CPF-DC
nct id: NCT01709539
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: 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)
description: 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.
measure: 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)
measure: 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)
measure: Survival after diagnosis of cancer or another serious disease
time frame: For up to 10 years after diagnosis
measure: Sick leave
time frame: During the diagnosis process and for 24 months after diagnosis
measure: Health care utilization
time frame: During the diagnosis process and for 24 months after diagnosis
measure: Overall medication use
time frame: During the diagnosis process and for 24 months after diagnosis
measure: Use of analgesics, antidepressants, and other psychotropic drugs
time frame: During the diagnosis process and for 24 months after diagnosis
measure: 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)
measure: 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)
measure: Serum inflammatory biomarker levels
time frame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
description: Serum inflammatory cytokine levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).
measure: 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)
description: Serum EGF receptor levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).
measure: Plasma microRNA levels
time frame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
description: Plasma microRNA levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).
measure: Telomere length
time frame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
description: 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).
arm group label: Diagnostiskt Centrum
arm group type: Experimental
description: Investigation at the primary care center followed by further investigation at Diagnostiskt Centrum, Kristianstad General Hospital
arm group label: Existing diagnostic procedures
arm group type: No Intervention
description: Investigation at the primary care center followed by further investigation at Helsingborg General Hospital
intervention type: Procedure
intervention name: Diagnostiskt Centrum
description: 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).
arm group label: Diagnostiskt Centrum
other name: Cancer diagnosis center, Kristianstad General Hospital
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Sundquist, MD, PhD
role: Principal Investigator
affiliation: Center for Primary Health Care Research, Malmö, Sweden
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Disease