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

Primary Purpose

CIN, Cervical Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
conventional cervix biopsy
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for CIN

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Charité

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

gentle tissue extraction (curettage)

conventional cervix biopsy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2013
Last Updated
April 17, 2013
Sponsor
Charite University, Berlin, Germany
Collaborators
Deutsche Klinik fuer Diagnostik
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1. Study Identification

Unique Protocol Identification Number
NCT01836588
Brief Title
New Gentle Biopsy Method of Cervix Lesions Using Superficial Curettage/Protocol ID: CX-CUR
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Deutsche Klinik fuer Diagnostik

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CIN, Cervical Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gentle tissue extraction (curettage)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
conventional cervix biopsy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional cervix biopsy
Intervention Description
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 Measure Information:
Title
pathological comparative results and all cause mobidity
Description
The comparison of these two methods to show that the pathologic diagnostical results are alike and the morbidity is less.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Achim Schneider, Prof. Dr., MPH
Organizational Affiliation
Charité University Berlin, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://frauenklinik.charite.de/en/
Description
Related Info

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

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