Evaluation of New Tissue Biomarkers for Cervical Cancer
Conditions
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.
Interventions
None listed
Sponsors
University of Luebeck
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed