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

Not Applicable

• Conditions: CIN; Cervical Cancer

• 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

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