CancerCPF-DCNCT01709539
Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden
A study testing Diagnostiskt Centrum in people with Cancer, run by Region Skane at 2 sites in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Diagnostiskt Centrum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2012to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Helsingborg General Hospital
Helsingborg, Skåne County, 251 87
Diagnostiskt Centrum, Kristianstad General Hospital
Kristianstad, Skåne County, 291 85
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Diagnostiskt Centrum
- Keywords
- Cancer diagnosis center, Time to diagnosis, Survival, Health economics, Biomarkers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostiskt CentrumProcedure or surgery
Also called Cancer diagnosis center, Kristianstad General Hospital
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).
| Study group | Role | What they receive |
|---|---|---|
| Diagnostiskt Centrum | Experimental | Investigation at the primary care center followed by further investigation at Diagnostiskt Centrum, Kristianstad General Hospital Receives: Procedure: Diagnostiskt Centrum |
| Existing diagnostic procedures | No intervention | Investigation at the primary care center followed by further investigation at Helsingborg General Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 37 days)
Secondary outcomes (9)
Time from first contact with primary care to decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital
Measured: 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
Measured: 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
Measured: For up to 10 years after diagnosis
Sick leave
Measured: During the diagnosis process and for 24 months after diagnosis
Health care utilization
Measured: During the diagnosis process and for 24 months after diagnosis
Overall medication use
Measured: During the diagnosis process and for 24 months after diagnosis
Use of analgesics, antidepressants, and other psychotropic drugs
Measured: During the diagnosis process and for 24 months after diagnosis
Time from information on diagnosis to decision about treatment
Measured: From information on diagnosis to decision about treatment (anticipated to be up to 2 months)
Time from information on diagnosis to initiation of treatment
Measured: From information on diagnosis to decision about treatment (anticipated to be up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2019
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Sundquist, MD, PhD, Principal investigator, Center for Primary Health Care Research, Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709539
- Sponsor's protocol ID
- CPF-DC
- Acronym
- CPF-DC
- Status last verified
- Apr 2022
- First submitted
- 12 Oct 2012
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sundquist J, Palmer K, Ryden S, Savblom 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.
PubMed 33330029
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden
- ClinicalTrials.gov ID
- NCT01709539
- Acronym / sponsor ID
- CPF-DC / CPF-DC
- Conditions
- Cancer
- Keywords
- Cancer diagnosis center, Time to diagnosis, Survival, Health economics, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2019 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostiskt Centrum | Experimental | Procedure: Diagnostiskt CentrumInvestigation at the primary care center followed by further investigation at Diagnostiskt Centrum, Kristianstad General Hospital |
| Existing diagnostic procedures | No intervention | –Investigation at the primary care center followed by further investigation at Helsingborg General Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostiskt CentrumAlso: Cancer diagnosis center, Kristianstad General HospitalPatients 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). | Procedure or surgery | Diagnostiskt Centrum |
Primary outcome
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.
9 secondary outcomes
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)
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)
Survival after diagnosis of cancer or another serious disease
Time frame: For up to 10 years after diagnosis
Sick leave
Time frame: During the diagnosis process and for 24 months after diagnosis
Health care utilization
Time frame: During the diagnosis process and for 24 months after diagnosis
Overall medication use
Time frame: During the diagnosis process and for 24 months after diagnosis
Use of analgesics, antidepressants, and other psychotropic drugs
Time frame: During the diagnosis process and for 24 months after diagnosis
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 33330029Sundquist J, Palmer K, Ryden S, Savblom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Sundquist, MD, PhD principal investigator
Center for Primary Health Care Research, Malmö, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostiskt Centrum in people with Cancer, run by Region Skane at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01709539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.