Luebeck University, Department for obstetrics and gynecology
Lübeck, Schleswig-Holstein, D-23538, Germany
Active, Not Recruiting
NCT Number: NCT02238990
Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions
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.
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Notify MeKey information
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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
Sponsors and collaborators
Lead sponsor
University of Luebeck
Other
Registry information
Official study title
Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions
Important dates
- Study start
- 2014
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Sep 12, 2014
- Registry last updated
- May 31, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.