Clinical trial NCT02238990: Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions
Official title: Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Evaluation of New Tissue Biomarkers for Cervical Cancer
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population is to be recruted from A. patients suffering from cervical cancer B. patients suffering from preinvasive cervical lesions

Brief 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.


Eligibility 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

Primary outcomes:
measure: CIN III (cervical intraepithelial neoplasia) lesions
timeFrame: three years
measure: cervical cancer
timeFrame: three years
measure: HPV
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Luebeck University, Department for obstetrics and gynecology
state: Schleswig Holstein
Study officials:
affiliation: University of Luebeck
name: Daniel Beyer, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Forschungszentrum Borstel
name: Torsten Goldmann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.