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

No results posted yet for this study

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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Entities

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 NCT03069872 on ClinicalTrials.gov