Suspended

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

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What is being tested

conventional cervix biopsy

+ conventional cervix biopsy

Procedure
Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Uterine Cervical Diseases

From 18 to 80 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorCharite University, Berlin, Germany
Last updated: April 22, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

This study focuses on a new, gentler method for extracting tissue from CIN lesions on the cervix. CIN stands for Cervical Intraepithelial Neoplasia, a condition where abnormal cells are found on the surface of the cervix. The study aims to compare this new method with the traditional cervix biopsy. The goal is to see if the new method can provide similar results but with less pain and fewer complications. This is particularly important for patients who have undergone a conisation, a procedure to remove a cone-shaped piece of tissue from the cervix to treat CIN. In this study, participants will experience both methods of tissue extraction. The new method involves a superficial curettage, a gentle scraping of the surface of the cervix. The results of this method will be compared with those of the traditional biopsy. The study will measure the diagnostic results of both methods and will also evaluate the level of discomfort and complications experienced by the participants. The primary outcome is to show that the new method can provide similar diagnostic results with less discomfort and fewer complications.

NCT01836588
Principal SponsorCharite University, Berlin, Germany
Last updated: April 22, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesUterine Cervical DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital DiseasesUterine Cervical Neoplasms

Criteria

3 inclusion criteria required to participate
Cytological suspicious CIN and a colposcopical impression of a major lesion (therapeutical endpoint: conisation)
Karnofsky-Index of 80 and higher
Women between 18 and 80
4 exclusion criteria prevent from participating
Drug addiction
Former malign disease oft he pelvic organs
Pregnancy
Serious internistic diseases

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Charité

Berlin, GermanyOpen Charité in Google Maps
SuspendedOne Study Center