New Gentle Biopsy Method of Cervix Lesions Using Superficial Curettage/Protocol ID: CX-CUR

NCT01836588 — Not applicable, Unknown, 300 participants, Charite University, Berlin, Germany

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT01836588
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, diagnostic
Enrollment	300 (Actual)
Sponsor	Charite University, Berlin, Germany (Other); collaborators: Deutsche Klinik fuer Diagnostik
Conditions	CIN, Cervical Cancer
Interventions	conventional cervix biopsy (Procedure)
Dates	start 2013-03-01, primary completion 2014-04-01 (estimated), completion 2014-04-01 (estimated), first posted 2013-04-22, last updated 2013-04-22
Locations	1 site in Germany

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
gentle tissue extraction (curettage)	Active comparator	Procedure: conventional cervix biopsy	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.
conventional cervix biopsy	Active comparator	Procedure: conventional cervix biopsy	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.

conventional cervix biopsy (Procedure): 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.

+Outcome measures

Primary outcomes

pathological comparative results and all cause mobidity [1 year]: The comparison of these two methods to show that the pathologic diagnostical results are alike and the morbidity is less.

+Eligibility

Sex: Female, ages: 18 Years to 80 Years

Inclusion Criteria:

* 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)

Exclusion Criteria:

* Former malign disease oft he pelvic organs
* Pregnancy
* Serious internistic diseases
* Drug addiction

+Locations (1)

Facility	City	Country	Status
Charité	Berlin	Germany

+Investigators

Achim Schneider, Prof. Dr., MPH, Study chair, Charité University Berlin, Germany