Endometrioid CarcinomaEAOCNCT01732432
Endometriosis and Frequency of Endometriosis-associated Ovarian Carcinomas (EAOC)
An observational study of Endometrioid Carcinoma and Clear Cell Carcinoma, run by University Hospital, Basel, Switzerland.
Trial summary
The purpose of this study is to determine whether a relationship exists between a previously established diagnosis of endometriosis and the consecutive risk of developing a clear cell or endometrioid ovarian carcinoma. Read more about this study
- Who is it for?
- Ages 30 to 85 years, women only
- Conditions the study is for
- Endometrioid Carcinoma, Clear Cell Carcinoma, Endometriosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Dec 2013
- Phase
- Observational
- 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 30 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: primary care hospital, university hospital
Who may be able to join
- endometrioid ovarian carcinoma
- clear cell ovarian carcinoma
- endometriosis, atypical endometriosis
- borderline tumors with endometriosis
Who cannot join
- undifferentiated carcinomas
- germ cell tumors
- sex cord-stromal tumors
About this study
Official title: Endometriosis and Frequency of Endometriosis-associated Ovarian Carcinomas (EAOC) - Epidemiological and Molecular Pathological Aspects
The purpose of this study is to determine whether a relationship exists between a previously established diagnosis of endometriosis and the consecutive risk of developing a clear cell or endometrioid ovarian carcinoma. All histopathological records since 1980 with these diagnoses (endometriosis, clear cell and endometrioid ovarian carcinoma) will be reviewed. Cancer registry data will be assessed to investigate differences in survival of women with endometriosis-associated ovarian carcinomas and those ovarian carcinoma patients without previous diagnosis of endometriosis.
- Conditions
- Endometrioid Carcinoma, Clear Cell Carcinoma, Endometriosis
- Medical subject headings
- Carcinoma, Endometrioid, Adenocarcinoma, Clear Cell, Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and clinical outcome of endometriosis-associated ovarian carcinomas
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrioid CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Obermann, MD, Dr., Principal investigator, University Hospital Basel, University of BaselEllen C Obermann, MD, Principal investigator, Institute of Pathology, University Hospital Basel, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732432
- Sponsor's protocol ID
- 210/12
- Acronym
- EAOC
- Status last verified
- Mar 2015
- First submitted
- 18 Nov 2012
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometriosis and Frequency of Endometriosis-associated Ovarian Carcinomas (EAOC) - Epidemiological and Molecular Pathological Aspects
- ClinicalTrials.gov ID
- NCT01732432
- Acronym / sponsor ID
- EAOC / 210/12
- Conditions
- Endometrioid Carcinoma, Clear Cell Carcinoma, Endometriosis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Nov 2012 (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.
The purpose of this study is to determine whether a relationship exists between a previously established diagnosis of endometriosis and the consecutive risk of developing a clear cell or endometrioid ovarian carcinoma. All histopathological records since 1980 with these diagnoses (endometriosis, clear cell and endometrioid ovarian carcinoma) will be reviewed. Cancer registry data will be assessed to investigate differences in survival of women with endometriosis-associated ovarian carcinomas and those ovarian carcinoma patients without previous diagnosis of endometriosis.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care hospital, university hospital
Key inclusion criteria (4 listed)
- endometrioid ovarian carcinoma
- clear cell ovarian carcinoma
- endometriosis, atypical endometriosis
- borderline tumors with endometriosis
Key exclusion criteria (3 listed)
- undifferentiated carcinomas
- germ cell tumors
- sex cord-stromal tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence and clinical outcome of endometriosis-associated ovarian carcinomas
Time frame: 30 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
Ellen Obermann, MD, Dr. principal investigator
University Hospital Basel, University of Basel
Ellen C Obermann, MD principal investigator
Institute of Pathology, University Hospital Basel, University of Basel
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrioid Carcinoma and Clear Cell Carcinoma, run by University Hospital, Basel, Switzerland.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
incidence and clinical outcome of endometriosis-associated ovarian carcinomas (time frame: 30 years). 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 1 Apr 2015.