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Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions
Conditions
The Study Focusses on the Evaluation of New Tissue Biomarkers for Cervical Cancer and Its Preinvasive Lesions.
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
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
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: N/A
Gender: Female
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
- 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
Location
Luebeck University, Department for obstetrics and gynecology
Luebeck, Schleswig Holstein, Germany
Status: Recruiting
Contact: Daniel Beyer, PD Dr. - +49 451 500 2141 - daniel.beyer@uksh.de
Start Date
September 2014
Sponsors
University of Luebeck
Source
University of Luebeck
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page