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

April 26, 2022 updated by: Region Skane
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
388

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Helsingborg, Skåne, Sweden, 251 87
        • Helsingborg General Hospital
      • Kristianstad, Skåne, Sweden, 291 85
        • Diagnostiskt Centrum, Kristianstad General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 37 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
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)
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
For up to 10 years after diagnosis
Sick leave
Time Frame: During the diagnosis process and for 24 months after diagnosis
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
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
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
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)
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)
From information on diagnosis to decision about treatment (anticipated to be up to 3 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
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).
During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
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).
During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
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).
During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan Sundquist, MD, PhD, Center for Primary Health Care Research, Malmö, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPF-DC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings