Ovarian CancerNCT03069872
A Trial of Fast Access to Transvaginal Ultrasound Through General Practice for Earlier Diagnosis of Ovarian Cancer
A study testing Transvaginal ultrasound in people with Ovarian Cancer, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Transvaginal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Apr 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GPs in the Central Denmark Region
- Women ≥40 years presenting with vague and non-specific symptoms
Who cannot join
- Women who fulfil access criteria for OC fast-track referral.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Access to Fast Transvaginal Ultrasound Through General Practice for Earlier Diagnosis of Ovarian Cancer
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.
Read more
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.
Read the detailed description
Background
Around 550 ovarian cancers (OCs) are diagnosed yearly in Denmark. Still, OC is the fourth commonest cause of cancer death amongst women in Denmark. Epithelial ovarian cancers (carcinomas) account for more than 90% of all OCs and Denmark has the second highest incidence in the world (15 per 100.000 women) with a life-time risk around 2%. The mean age at diagnosis is 63 years, and 80% are postmenopausal. In Denmark, 74% are diagnosed in FIGO stage III-IV and therefore at the time of diagnosis have regional or metastatic spread. Five-year survival with FIGO stage I is 83%, stage II 62%, stage III 23% and stage IV 11%. Thus, OC is detected at advanced stages with a very poor prognosis.
In 2008, a national fast-track system for cancer patients was established to ensure fast diagnosis and initiation of treatment. The fast-track system or cancer patient pathway (CPP) implies that patients presenting 'alarm' symptoms of e.g. OC will be referred immediately for diagnostic workup; no more than 14 days must pass from referral to initiation of treatment. Only about one quarter of the women with OC are referred primarily through this route. Therefore, additional accelerated routes are needed for the majority of women with OC.
A possibility could be access to fast TVU through general practice for women presenting with vague and non-specific symptoms that may represent underlying OC.
Aim
Develop and conduct training for general practitioners (GPs) in the latest knowledge of OC symptomatology. And at the same time investigate the feasibility and clinical implications in general practice of direct referral access to fast TVU, intended for women presenting with vague and non-specific symptoms.
Material and methods
GPs in Central Denmark Region are offered direct access to fast TVU for women aged 40 years or more who present vague and non-specific symptoms that could origin from OC, but which are not classified as alarm symptoms. Shortly afterwards all the GPs are offered a short lecture on OC symptomatology and instructions for the use of TVU for earlier diagnosis of OC through general practice. The lecture will be conducted by researchers from the research group.
Prior to investigation, all women who are referred to TVU will receive a consent form and a symptom-questionnaire. The symptom questionnaire focuses on the experienced symptoms during the past year.
After finished investigation, the TVU test results will return electronically to the referring GP.
The study period is one year. Data analysis will focus on the frequency of TVU use in general practice, action taken on test results and patient-reported symptoms prior to TVU.
Perspectives
The project will provide important new knowledge of the GPs referral practice when they suspect OC. For women presenting with vague and non-specific symptoms that may origin from OC, the introduction of TVU through general practice will provide new possibilities for evaluating the symptoms. Therefor introduction of TVU is a corner stone in the identification of more efficient ways to evaluate women at risk of developing OC.
This study will contribute with important knowledge of how to improve the diagnostics of OC in the future and may reduce time to diagnosis.
- Conditions
- Ovarian Cancer
- Being tested
- Transvaginal ultrasound
- Keywords
- Transvaginal ultrasound, General practice, Early diagnosis, Symptoms
- Medical subject headings
- Ovarian Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasoundDiagnostic test
Access to fast transvaginal ultrasound through general practice Develop and conduct training for general practicioners in the latest knowledge of ovarian cancer symptomatology
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All GPs in Central Denmark Region, are planned to be enrolled in the study during the one year study period. Receives: Diagnostic Test: Transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one year
Secondary outcomes (2)
Findings by TVU on women with vague and non-specific symptoms
An overview of all findings by TVU will be provided, and possible side effects will be assessed.
An algorithm for the use of TVU has been developed, and the principal investigator will tick a box specifying what has been discovered during the investigation. Findings by TVU is identified in the algorithm used for TVU and by ICD-10 codes.
Measured: one year
Ovarian Cancer (OC) stage distribution
Number of OC diagnosed in each cancer stage (FIGO I-IV)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start5 Apr 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Louise L Baun, MD, Principal investigator, Research Unit of General Practice, Aarhus UniversityPeter Vedsted, Professor, Study director, Research Unit of General Practice, Aarhus UniversityMargit Dueholm, As.Professor, Study chair, Aarhus University HospitalLone Kjeld Petersen, As.Professor, Study chair, Department of Gynaecology, Randers Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069872
- Sponsor's protocol ID
- 210278
- Status last verified
- Apr 2018
- First submitted
- 22 Feb 2017
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Fast Transvaginal Ultrasound Through General Practice for Earlier Diagnosis of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03069872
- Acronym / sponsor ID
- 210278
- Conditions
- Ovarian Cancer
- Keywords
- Transvaginal ultrasound, General practice, Early diagnosis, Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Around 550 ovarian cancers (OCs) are diagnosed yearly in Denmark. Still, OC is the fourth commonest cause of cancer death amongst women in Denmark. Epithelial ovarian cancers (carcinomas) account for more than 90% of all OCs and Denmark has the second highest incidence in the world (15 per 100.000 women) with a life-time risk around 2%. The mean age at diagnosis is 63 years, and 80% are postmenopausal. In Denmark, 74% are diagnosed in FIGO stage III-IV and therefore at the time of diagnosis have regional or metastatic spread. Five-year survival with FIGO stage I is 83%, stage II 62%, stage III 23% and stage IV 11%. Thus, OC is detected at advanced stages with a very poor prognosis.
In 2008, a national fast-track system for cancer patients was established to ensure fast diagnosis and initiation of treatment. The fast-track system or cancer patient pathway (CPP) implies that patients presenting 'alarm' symptoms of e.g. OC will be referred immediately for diagnostic workup; no more than 14 days must pass from referral to initiation of treatment. Only about one quarter of the women with OC are referred primarily through this route. Therefore, additional accelerated routes are needed for the majority of women with OC.
A possibility could be access to fast TVU through general practice for women presenting with vague and non-specific symptoms that may represent underlying OC.
Aim
Develop and conduct training for general practitioners (GPs) in the latest knowledge of OC symptomatology. And at the same time investigate the feasibility and clinical implications in general practice of direct referral access to fast TVU, intended for women presenting with vague and non-specific symptoms.
Material and methods
GPs in Central Denmark Region are offered direct access to fast TVU for women aged 40 years or more who present vague and non-specific symptoms that could origin from OC, but which are not classified as alarm symptoms. Shortly afterwards all the GPs are offered a short lecture on OC symptomatology and instructions for the use of TVU for earlier diagnosis of OC through general practice. The lecture will be conducted by researchers from the research group.
Prior to investigation, all women who are referred to TVU will receive a consent form and a symptom-questionnaire. The symptom questionnaire focuses on the experienced symptoms during the past year.
After finished investigation, the TVU test results will return electronically to the referring GP.
The study period is one year. Data analysis will focus on the frequency of TVU use in general practice, action taken on test results and patient-reported symptoms prior to TVU.
Perspectives
The project will provide important new knowledge of the GPs referral practice when they suspect OC. For women presenting with vague and non-specific symptoms that may origin from OC, the introduction of TVU through general practice will provide new possibilities for evaluating the symptoms. Therefor introduction of TVU is a corner stone in the identification of more efficient ways to evaluate women at risk of developing OC.
This study will contribute with important knowledge of how to improve the diagnostics of OC in the future and may reduce time to diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Transvaginal ultrasoundAll GPs in Central Denmark Region, are planned to be enrolled in the study during the one year study period. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- GPs in the Central Denmark Region
- Women ≥40 years presenting with vague and non-specific symptoms
Key exclusion criteria (1 listed)
- Women who fulfil access criteria for OC fast-track referral.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal ultrasoundAccess to fast transvaginal ultrasound through general practice Develop and conduct training for general practicioners in the latest knowledge of ovarian cancer symptomatology | Diagnostic test | Intervention |
Primary outcome
Frequency of TVU use
Time frame: one year
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.
Action taken on test results
Time frame: one year
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.
Patient-reported symptoms before TVU investigation
Time frame: one year
All women who are referred to TVU will receive a questionnaire prior to investigation, regarding experienced symptoms during the past year.
Indication for fast TVU
Time frame: one year
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.
2 secondary outcomes
Findings by TVU on women with vague and non-specific symptoms
Time frame: one year
Ovarian Cancer (OC) stage distribution
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Louise L Baun, MD principal investigator
Research Unit of General Practice, Aarhus University
Peter Vedsted, Professor study director
Research Unit of General Practice, Aarhus University
Margit Dueholm, As.Professor study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal ultrasound in people with Ovarian Cancer, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of TVU use (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.