Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions

University of Luebeck

Status: Active, not recruiting

Conditions: Evaluation of New Tissue Biomarkers for Cervical Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02238990

UKSH-HL-14-099 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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