A Trial of Fast Access to Transvaginal Ultrasound Through General Practice for Earlier Diagnosis of Ovarian Cancer
NCT03069872 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 490
Last updated 2020-04-02
Summary
Background
Ovarian cancer (OC) is a disease with a poor prognosis due to diagnosis at late stage. Early-stage OC presents with non-specific and vague symptoms and therefore OC usually is not detected until reaching an advanced stage. From 2008, Danish general practitioners (GPs) could urgently refer patients suspected of having OC to standardized cancer patient pathways (CPPs). The CPP is designed for women presenting specific signs and alarm symptoms, and is supposed to shorten the pathway from suspicion to treatment.
Hypothesis
Direct access to fast transvaginal ultrasound (TVU) through general practice is feasible in earlier diagnosis of OC.
Aim
The aim of this study is to assess the implementation and clinical implications of direct referral access to fast TVU through general practice.
Materials and methods
The study is a feasibility study and GPs from in Central Denmark Region are offered direct access to fast TVU for women aged 40 years or more who present symptoms that could origin from OC, but which are not classified as alarm symptoms. The GPs will receive education about updated knowledge on OC symptoms and the use of the guideline for earlier diagnosis of OC in general practice. The study period is 1 year.
Perspectives
There is a great need to test rational strategies for diagnosing OC at an earlier stage in order to improve survival. For women who do not fulfil access criteria for the CPP, and for whom the main prospect for earlier diagnosis is improved identification of symptomatic OC, this study may provide important new knowledge of how to facilitate the diagnostics of OC in the future and reduce time to diagnosis and improve survival.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
Transvaginal ultrasound
Access to fast transvaginal ultrasound through general practice Develop and conduct training for general practicioners in the latest knowledge of ovarian cancer symptomatology
Sponsors & Collaborators
-
University of Aarhus
lead OTHER
Principal Investigators
-
Marie-Louise L Baun, MD · Research Unit of General Practice, Aarhus University
-
Peter Vedsted, Professor · Research Unit of General Practice, Aarhus University
-
Margit Dueholm, As.Professor · Aarhus University Hospital
-
Lone Kjeld Petersen, As.Professor · Department of Gynaecology, Randers Regional Hospital
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-05
- Primary Completion
- 2018-04-30
- Completion
- 2018-04-30
Countries
- Denmark
Study Locations
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