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

Cancer Clinical Trial

— CPF-DC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709539
• Other study ID #: CPF-DC
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 2021

Study information

• Verified date: April 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: December 2021
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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).

Locations

Country	Name	City	State
Sweden	Helsingborg General Hospital	Helsingborg	Skåne
Sweden	Diagnostiskt Centrum, Kristianstad General Hospital	Kristianstad	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	Survival after diagnosis of cancer or another serious disease		For up to 10 years after diagnosis
Secondary	Sick leave		During the diagnosis process and for 24 months after diagnosis
Secondary	Health care utilization		During the diagnosis process and for 24 months after diagnosis
Secondary	Overall medication use		During the diagnosis process and for 24 months after diagnosis
Secondary	Use of analgesics, antidepressants, and other psychotropic drugs		During the diagnosis process and for 24 months after diagnosis
Secondary	Time from information on diagnosis to decision about treatment		From information on diagnosis to decision about treatment (anticipated to be up to 2 months)
Secondary	Time from information on diagnosis to initiation of treatment		From information on diagnosis to decision about treatment (anticipated to be up to 3 months)