Ovarian Epithelial CancerLUDOCNCT02062697
Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes.
A study testing Lavage of the Cavum uteri and proximal fallopian tubes and Liquid-PAP smear in people with Ovarian Epithelial Cancer, run by Medical University of Vienna at 6 sites in 4 countries.
Trial summary
Epithelial Ovarian cancer (EOC) is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Epithelial Cancer
- What is being tested?
- Lavage of the Cavum uteri and proximal fallopian tubes and Liquid-PAP smear
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Feb 2012to Nov 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- suspected ovarian cancer
- verified ovarian cancer
Who cannot join
- pregnant
- incapacitated persons
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany3 sites
Charité University - Campus Virchow Clinic
Berlin, 13353
Klinik Essen Mitte (KEM)
Essen, 92 45136
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246
Austria1 site
Medical University Vienna, Dptm. of Obstetrics & Gynaecology
Vienna, 1090
Belgium1 site
University Hospitals Leuven - Department of Obstetrics and Gynaecology
Leuven, 3000
Czechia1 site
Charles University, Pilsen - Medical Faculty Hospital, Department of Obstetrics and Gynecology
Pilsen, Plzeň Region, 301 66
About this study
Official title: Pilot Study of the Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes - LUDOC Study
Epithelial Ovarian cancer (EOC) is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually.
State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.
Read more
In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.
Aim of this study:
There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.
Read the detailed description
Epithelial Ovarian cancer is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually. Treatment and survival of the patients depend primarily on the stage of the disease. Of all EOC patients only 25% are diagnosed at an early stage while the tumour is confined to the pelvis. In these cases the five-year survival rate is 80% to 90% and the disease can often be cured by the combination of surgery and chemotherapy. Unfortunately, almost 75% of women affected have advanced stage disease with metastatic spread throughout the abdominal cavity or to retroperitoneal lymph nodes at the time of diagnosis; five-year survival rates drop to 10%-30% for advanced disease, despite maximum surgical effort and combination chemotherapy.
State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.
In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.
Aim of this study:
There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.
- Conditions
- Ovarian Epithelial Cancer
- Being tested
- Lavage of the Cavum uteri and proximal fallopian tubes, Liquid-PAP smear
- Keywords
- Neoplasms, Glandular and Epithelial, Ovarian Neoplasms, Ovarian cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavage of the Cavum uteri and proximal fallopian tubesProcedure or surgery
Also called MF 13005 (MADICOPLAST Catheter)
Liquid-PAP smearProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Epithelial Cancer | Other | * Lavage of the Cavum uteri and proximal fallopian tubes
* Liquid-PAP (Papanicolaou) smear Receives: Procedure: Lavage of the Cavum uteri and proximal fallopian tubes; Procedure: Liquid-PAP smear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of EOCs by mutation analysis in the lavage of the uterine cavity.
If the adnexal tumor removed turns out to be an EOC, mutation analysis will be carried out applying the sensitive massively parallel sequencing method published by Kinde et al. Mutations in the following genes will be analysed: AKT1, APC, ARID1A, BRAF, CTNNB1, CSMD3, CDKN2A, EGFR, FBXW7, FAT3, FGFR2, KRAS, MLL2, NRAS, PTEN, PIK3CA, PIK3R1, PPP2R1A, PIK3R, RNF43, and TP53.
Measured: Day 1
Secondary outcomes (1)
Detection of EOCs by mutation analysis of the liquid-based Pap smear.
Obtaining material from the uterine cervix by applying a liquid-based Pap smear technique to directly compare the two sampling techniques - Lavage and liquid-based Pap.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2012
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Speiser, Prof.MD,, Medical University of Vienna
- Investigators
- Paul Speiser, Univ.Prof.Dr., Principal investigator, Medical University Vienna, Dptm. of Obstetrics & Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062697
- Sponsor's protocol ID
- EK 1148/2011
- Acronym
- LUDOC
- Status last verified
- Feb 2020
- First submitted
- 20 Jan 2014
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes - LUDOC Study
- ClinicalTrials.gov ID
- NCT02062697
- Acronym / sponsor ID
- LUDOC / EK 1148/2011
- Conditions
- Ovarian Epithelial Cancer
- Keywords
- Neoplasms, Glandular and Epithelial, Ovarian Neoplasms, Ovarian cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 14 Feb 2014 (estimated)
- 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.
Epithelial Ovarian cancer (EOC) is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually.
State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.
In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.
Aim of this study:
There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.
Detailed description
Epithelial Ovarian cancer is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually. Treatment and survival of the patients depend primarily on the stage of the disease. Of all EOC patients only 25% are diagnosed at an early stage while the tumour is confined to the pelvis. In these cases the five-year survival rate is 80% to 90% and the disease can often be cured by the combination of surgery and chemotherapy. Unfortunately, almost 75% of women affected have advanced stage disease with metastatic spread throughout the abdominal cavity or to retroperitoneal lymph nodes at the time of diagnosis; five-year survival rates drop to 10%-30% for advanced disease, despite maximum surgical effort and combination chemotherapy.
State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.
In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.
Aim of this study:
There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian Epithelial Cancer | Other | Procedure: Lavage of the Cavum uteri and proximal fallopian tubes, Procedure: Liquid-PAP smear* Lavage of the Cavum uteri and proximal fallopian tubes * Liquid-PAP (Papanicolaou) smear |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suspected ovarian cancer
- verified ovarian cancer
Key exclusion criteria (2 listed)
- pregnant
- incapacitated persons
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 |
|---|---|---|
| Lavage of the Cavum uteri and proximal fallopian tubesAlso: MF 13005 (MADICOPLAST Catheter) | Procedure or surgery | Ovarian Epithelial Cancer |
| Liquid-PAP smear | Procedure or surgery | Ovarian Epithelial Cancer |
Primary outcome
Detection of EOCs by mutation analysis in the lavage of the uterine cavity.
Time frame: Day 1
If the adnexal tumor removed turns out to be an EOC, mutation analysis will be carried out applying the sensitive massively parallel sequencing method published by Kinde et al. Mutations in the following genes will be analysed: AKT1, APC, ARID1A, BRAF, CTNNB1, CSMD3, CDKN2A, EGFR, FBXW7, FAT3, FGFR2, KRAS, MLL2, NRAS, PTEN, PIK3CA, PIK3R1, PPP2R1A, PIK3R, RNF43, and TP53.
1 secondary outcome
Detection of EOCs by mutation analysis of the liquid-based Pap smear.
Time frame: Day 1
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 25 Feb 2020.
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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.
Paul Speiser, Univ.Prof.Dr. principal investigator
Medical University Vienna, Dptm. of Obstetrics & Gynaecology
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavage of the Cavum uteri and proximal fallopian tubes and Liquid-PAP smear in people with Ovarian Epithelial Cancer, run by Medical University of Vienna at 6 sites in 4 countries.
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 2 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Austria, Belgium, Czechia. 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?
Detection of EOCs by mutation analysis in the lavage of the uterine cavity. (time frame: Day 1). 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 25 Feb 2020.