Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions
- Conditions
- Evaluation of New Tissue Biomarkers for Cervical Cancer
- Registration Number
- NCT02238990
- Lead Sponsor
- University of Luebeck
- Brief Summary
The following trial is a multicenter and prospective research trial of the colposcopy unit of luebeck university and the national research center in Borstel, Germany.
The study is to identify and evaluate new biomarkers in human papilloma virus (HPV) associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples being removed during conizations and/or hysterectomies are to be fixed in HOPE's solution and analyzed according to their transcriptomes and methylosome. The hereby found candidates are to be validated using immunohistochemistry and RT \[real-time\] -PCR \[polymerase chain reaction\].
The project is meant to be followed by continuous studies developing a new test describing the malignant potential of HPV associated genital lesions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- Positive informed consent
- Patients with suspected preinvasive genital lesion
- Patients with confirmed genital lesion (both preinvasive and invasive)
- Contact via dept. of obs/gyn of luebeck university
- Complete set of data
- Incomplete set of data
- Negative informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CIN III (cervical intraepithelial neoplasia) lesions three years number of CIN III lesions
cervical cancer three years number of cervical cancer probes
HPV three years number and type of HPV infection of the analyzed probes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Luebeck University, Department for obstetrics and gynecology
🇩🇪Luebeck, Schleswig Holstein, Germany