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Trial Title:
Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions
NCT ID:
NCT02238990
Condition:
Evaluation of New Tissue Biomarkers for Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
The population is to be recruted from A. patients suffering from cervical cancer B.
patients suffering from preinvasive cervical lesions
Sampling method:
Probability Sample
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
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Luebeck University, Department for obstetrics and gynecology
Address:
City:
Luebeck
Zip:
D-23538
Country:
Germany
Start date:
September 2014
Completion date:
December 1, 2030
Lead sponsor:
Agency:
University of Luebeck
Agency class:
Other
Source:
University of Luebeck
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02238990
