A Trial of Fast Access to Transvaginal Ultrasound Through General Practice for Earlier Diagnosis of Ovarian Cancer

NCT03069872 | Completed DMC

• 1 other identifier: 210278
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief 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

Ovarian Cancer

Keywords

Transvaginal ultrasound; General practice; Early diagnosis; Symptoms

Outcome Measures

Primary Outcomes (4)

• Frequency of TVU use

  TVU will be requested electronically through an online referral-system used by Danish GPs. This outcome will be evaluated descriptively by illustrating the relation between time and use of TVU.

  one year

• Action taken on test results

  After all TVU investigations, a discharge summary will be send electronically to the referring GP. If indicated, instructions for follow-up investigations is stated in the discharge summary. To evaluate if GPs follow these instructions, data on discharge summary recommended follow-up are compared to data on follow-up referrals made by the GPs. This outcome will be evaluated descriptively.

  one year

• Patient-reported symptoms before TVU investigation

  All women who are referred to TVU will receive a questionnaire prior to investigation, regarding experienced symptoms during the past year.

  one year

• Indication for fast TVU

  GPs refer women to TVU electronically. Information about indications for the investigation, is required in the referral. These informations will be used to evaluate the GPs reasons for referring the women to TVU and will be evaluated descriptively.

  one year

Secondary Outcomes (2)

• Findings by TVU on women with vague and non-specific symptoms

  one year

• Ovarian Cancer (OC) stage distribution

  one year

Study Arms (1)

Intervention

EXPERIMENTAL

All GPs in Central Denmark Region, are planned to be enrolled in the study during the one year study period.

Diagnostic Test: Transvaginal ultrasound

Interventions

Transvaginal ultrasound DIAGNOSTIC_TEST

Access to fast transvaginal ultrasound through general practice Develop and conduct training for general practicioners in the latest knowledge of ovarian cancer symptomatology

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GPs in the Central Denmark Region
• Women ≥40 years presenting with vague and non-specific symptoms

You may not qualify if:

• Women who fulfil access criteria for OC fast-track referral.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University

Aarhus, Region Midt, 8000, Denmark

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Disease

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie-Louise L Baun, MD

  Research Unit of General Practice, Aarhus University

  PRINCIPAL INVESTIGATOR

• Peter Vedsted, Professor

  Research Unit of General Practice, Aarhus University

  STUDY DIRECTOR

• Margit Dueholm, As.Professor

  Aarhus University Hospital

  STUDY CHAIR

• Lone Kjeld Petersen, As.Professor

  Department of Gynaecology, Randers Regional Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: April 5, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: April 2, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)