Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Evaluation of New Tissue Biomarkers for Cervical Cancer
- Sponsor
- University of Luebeck
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- CIN III (cervical intraepithelial neoplasia) lesions
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Daniel Alexander Beyer
Priv.-Doz.Dr.med.habil.
University of Luebeck
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Incomplete set of data
- •Negative informed consent
Outcomes
Primary Outcomes
CIN III (cervical intraepithelial neoplasia) lesions
Time Frame: three years
number of CIN III lesions
cervical cancer
Time Frame: three years
number of cervical cancer probes
HPV
Time Frame: three years
number and type of HPV infection of the analyzed probes