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

Not Applicable

• Conditions: CIN; Cervical Cancer
• Interventions: Procedure: conventional cervix biopsy

• Registration Number: NCT01836588
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-13
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-17
• Last Update Submitted: 2013-04-17
• Study First Posted: 2013-04-22
• Last Update Posted: 2013-04-22
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gentle tissue extraction (curettage)	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	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Charité; 🇩🇪 Berlin, Germany