NCT01836588

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

1.1 years

First QC Date

March 13, 2013

Last Update Submit

April 17, 2013

Conditions

CINCervical Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

gentle tissue extraction (curettage)

ACTIVE COMPARATOR

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

conventional cervix biopsy

ACTIVE COMPARATOR

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

Interventions

conventional cervix biopsyPROCEDURE

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 biopsygentle tissue extraction (curettage)

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Former malign disease oft he pelvic organs
  • Pregnancy
  • Serious internistic diseases
  • Drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, 10117, Germany

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Achim Schneider, Prof. Dr., MPH

    Charité University Berlin, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

March 13, 2013

First Posted

April 22, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations

DE(1)