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Completed

NCT Number: NCT01709539

Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsingborg General Hospital, Helsingborg, Skåne County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostiskt Centrum

Procedure

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

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

  2. 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)

  3. Survival after diagnosis of cancer or another serious disease

    Time frame: For up to 10 years after diagnosis

  4. Sick leave

    Time frame: During the diagnosis process and for 24 months after diagnosis

  5. Health care utilization

    Time frame: During the diagnosis process and for 24 months after diagnosis

  6. Overall medication use

    Time frame: During the diagnosis process and for 24 months after diagnosis

  7. Use of analgesics, antidepressants, and other psychotropic drugs

    Time frame: During the diagnosis process and for 24 months after diagnosis

  8. 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)

  9. 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)

Other outcomes

  1. Serum inflammatory biomarker levels

    Time frame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)

    Serum inflammatory cytokine levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).

  2. 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)

    Serum EGF receptor levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).

  3. Plasma microRNA levels

    Time frame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)

    Plasma microRNA levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).

  4. Telomere length

    Time frame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)

    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).

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Acronym: CPF-DC

Important dates

Study start
2012
Primary completion
2019
Study completion
2021
First posted
Oct 18, 2012
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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