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A Feasibility Study of Direct Access to an Abdominal ´Yes-No´ Pathway for Primary Care Patients

NCT03878940 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-04-16

No results posted yet for this study

Summary

Background To optimise cancer outcome in Denmark, cancer diagnostic pathways should, beside cancer patient pathways (CPP) for alarm symptoms, also include a pathway for patients with vague and non-specific symptoms. Research has demonstrated that 50% of all cancers do not qualify for specific CPPs, although the majority of patients initially present symptoms in general practice.

Hypothesis Direct access to an abdominal 'yes-no' pathway is feasible in general practice. Aim The aim of this study is to assess the implementation and clinical implications of direct access to an abdominal 'yes-no' pathway for primary care patients with vague and non-specific abdominal symptoms Materials and methods The study is a feasibility study in which all general practitioners (GPs) in the municipality of Silkeborg in Central Denmark Region are offered direct access to a newly developed abdominal ´yes-no´ pathway for both men and women aged 30 years or above, who present vague and non-specific abdominal symptoms in primary care. The abdominal ´yes-no´ pathway consists of: 1) Medical and objective examination, 2) Selected blood samples and a Fecal Immunochemical test (FIT), and 3) Abdominal ultrasound (US) and transvaginal US (TVUS) (for women).

Perspectives This study will provide important knowledge on how to improve abdominal cancer diagnostics in general practice.

Conditions

Interventions

DIAGNOSTIC_TEST

Abdominal ´yes-no´ pathway

A set of blood samples, a FIT, and an abdominal US (and a TVUS in women)

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Peter Vedsted · Research Unit of General Practice, Aarhus, Denmark

  • Henry Jensen · Research Unit of General Practice, Aarhus, Denmark

  • Henning Gronbaek · Dept. of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark

  • Henning Glerup · Diagnostic Center, Silkeborg Regional Hospital, Denmark

  • Nanna Holt Jessen · Research Unit of General Practice, Aarhus, Denmark

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-09-30
Completion
2020-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878940 on ClinicalTrials.gov