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

NCT01709539 | Completed DMC

• 1 other identifier: CPF-DC
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer

Keywords

Cancer diagnosis center; Time to diagnosis; Survival; Health economics; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

• 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)

• Survival after diagnosis of cancer or another serious disease

  For up to 10 years after diagnosis

• Sick leave

  During the diagnosis process and for 24 months after diagnosis

• Health care utilization

  During the diagnosis process and for 24 months after diagnosis

Other Outcomes (4)

• Serum inflammatory biomarker levels

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

• Serum epidermal growth factor (EGF) receptor levels

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

• Plasma microRNA levels

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

Study Arms (2)

Diagnostiskt Centrum

EXPERIMENTAL

Investigation at the primary care center followed by further investigation at Diagnostiskt Centrum, Kristianstad General Hospital

Procedure: Diagnostiskt Centrum

Existing diagnostic procedures

NO INTERVENTION

Investigation at the primary care center followed by further investigation at Helsingborg General Hospital

Interventions

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).

Also known as: Cancer diagnosis center, Kristianstad General Hospital

Diagnostiskt Centrum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Region Skane: lead

Study Sites (2)

Helsingborg General Hospital

Helsingborg, Skåne County, 251 87, Sweden

Location

Diagnostiskt Centrum, Kristianstad General Hospital

Kristianstad, Skåne County, 291 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33330029 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jan Sundquist, MD, PhD

  Center for Primary Health Care Research, Malmö, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 18, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

SE (2)