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

Cervical Cancer Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01836588
• Other study ID #: CX-CUR
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 13, 2013
• Last updated: April 17, 2013
• Start date: March 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Cancer
• CIN
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Charité	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Deutsche Klinik fuer Diagnostik

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No

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