Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03069872
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2017-02-22
Brief Title:
A Trial of Fast Access to Transvaginal Ultrasound Through General Practice for Earlier Diagnosis of Ovarian Cancer
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Access to Fast Transvaginal Ultrasound Through General Practice for Earlier Diagnosis of Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 100000 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 eg 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
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 100000 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None