Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions
NCT ID: NCT02238990
Last Updated: 2022-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2014-09-30
2030-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Negative informed consent
FEMALE
Yes
Sponsors
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University of Luebeck
OTHER
Responsible Party
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Daniel Alexander Beyer
Priv.-Doz.Dr.med.habil.
Principal Investigators
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Daniel Beyer, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Luebeck
Torsten Goldmann, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Forschungszentrum Borstel
Locations
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Luebeck University, Department for obstetrics and gynecology
Lübeck, Schleswig-Holstein, Germany
Countries
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References
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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.
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.
Other Identifiers
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UKSH-HL-14-099
Identifier Type: OTHER
Identifier Source: secondary_id
UKSH-HL-14-099
Identifier Type: -
Identifier Source: org_study_id
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