- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02238990
Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions
Biomarkerscreening Via Transcriptome and Methylosome Analysis 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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Schleswig Holstein
-
Luebeck, Schleswig Holstein, Germany, D-23538
- Luebeck University, Department for obstetrics and gynecology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CIN III (cervical intraepithelial neoplasia) lesions
Time Frame: three years
|
number of CIN III lesions
|
three years
|
cervical cancer
Time Frame: three years
|
number of cervical cancer probes
|
three years
|
HPV
Time Frame: three years
|
number and type of HPV infection of the analyzed probes
|
three years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Beyer, PD Dr., University of Luebeck
- Principal Investigator: Torsten Goldmann, Prof. Dr., Forschungszentrum Borstel
Publications and helpful links
General Publications
- Massad LS, Jeronimo J, Katki HA, Schiffman M; National Institutes of Health/American Society for Colposcopy and Cervical Pathology Research Group. The accuracy of colposcopic grading for detection of high-grade cervical intraepithelial neoplasia. J Low Genit Tract Dis. 2009 Jul;13(3):137-44. doi: 10.1097/LGT.0b013e31819308d4.
- Apgar BS, Kittendorf AL, Bettcher CM, Wong J, Kaufman AJ. Update on ASCCP consensus guidelines for abnormal cervical screening tests and cervical histology. Am Fam Physician. 2009 Jul 15;80(2):147-55.
- Gagne HM. Colposcopy of the vagina and vulva. Obstet Gynecol Clin North Am. 2008 Dec;35(4):659-69; x. doi: 10.1016/j.ogc.2008.10.002.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKSH-HL-14-099 (Other Identifier: Ethicscomittee Luebeck 14-099)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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