CINNCT01836588
New Gentle Biopsy Method of Cervix Lesions Using Superficial Curettage/Protocol ID: CX-CUR
A study testing conventional cervix biopsy in people with CIN and Cervical Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix will bring the same conclusion than the conventional cervix biopsy, but with less pain and morbidity, after patients were undergoing a conisation in order to treat CIN. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- CIN, Cervical Cancer
- What is being tested?
- conventional cervix biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Apr 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between 18 and 80
- Karnofsky-Index of 80 and higher
- Cytological suspicious CIN and a colposcopical impression of a major lesion (therapeutical endpoint: conisation)
Who cannot join
- Former malign disease oft he pelvic organs
- Pregnancy
- Serious internistic diseases
- Drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix will bring the same conclusion than the conventional cervix biopsy, but with less pain and morbidity, after patients were undergoing a conisation in order to treat CIN.
- Conditions
- CIN, Cervical Cancer
- Being tested
- conventional cervix biopsy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional cervix biopsyProcedure or surgery
Object of this study is the evaluation of two different methods of gaining cervical tissue in order to determine whether, and if so in what extent, a CIN is existent. The first method is a cervical biopsy, the second method is a gentle tissue saving curettage of the cervix uteri. Also is to be investigated that the latter method shows a reduction of pain and morbidity after the procedure.
For this reason the pathological outcome of the two methods will be compared to the result of a conisation, which will be received by the patient to cure their cervical lesions.
| Study group | Role | What they receive |
|---|---|---|
| gentle tissue extraction (curettage) | Active comparator | Object of this study is the evaluation of two different methods of gaining cervical tissue in order to determine whether, and if so in what extent, a CIN is existent. The first method is a cervical biopsy, the second method is a gentle tissue saving curettage of the cervix uteri. Also is to be investigated that the latter method shows a reduction of pain and morbidity after the procedure.
For this reason the pathological outcome of the two methods will be compared to the result of a conisation, which will be received by the patient to cure their cervical lesions. Receives: Procedure: conventional cervix biopsy |
| conventional cervix biopsy | Active comparator | Object of this study is the evaluation of two different methods of gaining cervical tissue in order to determine whether, and if so in what extent, a CIN is existent. The first method is a cervical biopsy, the second method is a gentle tissue saving curettage of the cervix uteri. Also is to be investigated that the latter method shows a reduction of pain and morbidity after the procedure.
For this reason the pathological outcome of the two methods will be compared to the result of a conisation, which will be received by the patient to cure their cervical lesions. Receives: Procedure: conventional cervix biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological comparative results and all cause mobidity
The comparison of these two methods to show that the pathologic diagnostical results are alike and the morbidity is less.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CINStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Klinik fuer Diagnostik
- Responsible party
- Principal investigator, Tim Schellenberg, Charite University, Berlin, Germany
- Investigators
- Achim Schneider, Prof. Dr., MPH, Study chair, Charité University Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836588
- Sponsor's protocol ID
- CX-CUR
- Status last verified
- Apr 2013
- First submitted
- 13 Mar 2013
- Last updated
- 22 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Gentle Biopsy Method of Cervix Lesions Using Superficial Curettage/Protocol ID: CX-CUR
- ClinicalTrials.gov ID
- NCT01836588
- Acronym / sponsor ID
- CX-CUR
- Conditions
- CIN, Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Deutsche Klinik fuer Diagnostik
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 22 Apr 2013 (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.
It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix will bring the same conclusion than the conventional cervix biopsy, but with less pain and morbidity, after patients were undergoing a conisation in order to treat CIN.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gentle tissue extraction (curettage) | Active comparator | Procedure: conventional cervix biopsyObject of this study is the evaluation of two different methods of gaining cervical tissue in order to determine whether, and if so in what extent, a CIN is existent. The first method is a cervical biopsy, the second method is a gentle tissue saving curettage of the cervix uteri. Also is to be investigated that the latter method shows a reduction of pain and morbidity after the procedure. For this reason the pathological outcome of the two methods will be compared to the result of a conisation, which will be received by the patient to cure their cervical lesions. |
| conventional cervix biopsy | Active comparator | Procedure: conventional cervix biopsyObject of this study is the evaluation of two different methods of gaining cervical tissue in order to determine whether, and if so in what extent, a CIN is existent. The first method is a cervical biopsy, the second method is a gentle tissue saving curettage of the cervix uteri. Also is to be investigated that the latter method shows a reduction of pain and morbidity after the procedure. For this reason the pathological outcome of the two methods will be compared to the result of a conisation, which will be received by the patient to cure their cervical lesions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women between 18 and 80
- Karnofsky-Index of 80 and higher
- Cytological suspicious CIN and a colposcopical impression of a major lesion (therapeutical endpoint: conisation)
Key exclusion criteria (4 listed)
- Former malign disease oft he pelvic organs
- Pregnancy
- Serious internistic diseases
- Drug addiction
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 |
|---|---|---|
| conventional cervix biopsyObject of this study is the evaluation of two different methods of gaining cervical tissue in order to determine whether, and if so in what extent, a CIN is existent. The first method is a cervical biopsy, the second method is a gentle tissue saving curettage of the cervix uteri. Also is to be investigated that the latter method shows a reduction of pain and morbidity after the procedure. For this reason the pathological outcome of the two methods will be compared to the result of a conisation, which will be received by the patient to cure their cervical lesions. | Procedure or surgery | conventional cervix biopsy, gentle tissue extraction (curettage) |
Primary outcome
pathological comparative results and all cause mobidity
Time frame: 1 year
The comparison of these two methods to show that the pathologic diagnostical results are alike and the morbidity is less.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Related InfoLink provided by the sponsor.
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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.
Achim Schneider, Prof. Dr., MPH study chair
Charité University Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional cervix biopsy in people with CIN and Cervical Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Apr 2013. 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 Germany. 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?
Results are not available in the source record.
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?
pathological comparative results and all cause mobidity (time frame: 1 year). 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 22 Apr 2013.