Recently, a diagnostic fast track for patients with serious non-organ-specific symptoms and signs of cancer was established in Denmark. For patients without cancer diagnosed within the first month, the prognosis is currently unclear.
A retrospective cohort study of 926 patients referred to Diagnostic Outpatient Clinic (DOC) at Herlev Hospital from April 2012 to December 2013. Baseline clinical parameters were collected from patient records. Time to cancer, death, cancer specific mortality (CSM), and death due to other causes were recorded until May, 2016. 724 patients were identified without cancer one month after examination and divided into 2 sub-cohorts based on the initial assessment: true negatives (TNs; patients diagnosed without cancer at DOC and after 1 month) and false positives (FPs; patients referred from DOC with suspicion of cancer, but without cancer the 1. month). Cumulative incidence of cancer, death, CSM, and death from other causes were estimated by the Aalen-Johansen estimator using 31 days after initial assessment as baseline. Hazard radios (HR) and 95% confidence intervals (CIs) for the initial evaluation were estimated in Cox models with cancer and mortality, respectively, as outcomes.
Clinical characteristics of the 724 patients: median age 65 years (range 17-92); 44% were men; 70% were referred from their general practitioner; 43% were former/current smokers; 18% were former/current alcohol abusers. The median age (p
Ruling out cancer by investigation at DOC was associated with low risk of subsequent cancer and the NPV was high. The FPs had higher risk of cancer, mortality, and CSM compared to the TNs.
Clinical trial identification
This is not a clinical trial, but a retrospective cohort study.
The project have been approved by the Danish Data Protection Agency (local j.nr.: HGH-2016-052, I-Suite nr.: 04524) and by the Danish Health and Medicine Authority (nr. 3-3013-1588/1/)
Legal entity responsible for the study
Claus Larsen Feltoft
Department of Internal Medicine, Herlev and Gentofte Hospital (no specific grant number); Danish Cancer Society (grant number: R152-A9695-16-S7).
All authors have declared no conflicts of interest.