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

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ClinicalTrials.gov Identifier: NCT01836588
Recruitment Status : Unknown
Verified April 2013 by Tim Schellenberg, Charite University, Berlin, Germany.
Recruitment status was:  Enrolling by invitation
First Posted : April 22, 2013
Last Update Posted : April 22, 2013
Sponsor:
Collaborator:
Deutsche Klinik fuer Diagnostik
Information provided by (Responsible Party):
Tim Schellenberg, 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.

Condition or disease Intervention/treatment Phase
CIN Cervical Cancer Procedure: conventional cervix biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : March 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: gentle tissue extraction (curettage)

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.

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.


Active Comparator: 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.

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.





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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836588


Locations
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Germany
Charité
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Deutsche Klinik fuer Diagnostik
Investigators
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Study Chair: Achim Schneider, Prof. Dr., MPH Charité University Berlin, Germany

Additional Information:
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Responsible Party: Tim Schellenberg, physician, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01836588    
Other Study ID Numbers: CX-CUR
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female