Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions

NCT02238990 · tracked via the Priya Life Science Germany tracker

Sponsor

University of Luebeck

Phase

Observational

Started

2014-09

Last updated

2022-05-31

Condition(s) studied

Evaluation of New Tissue Biomarkers for Cervical Cancer

Study 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

Sex

FEMALE

Min age

—

Max age

—

Healthy volunteers

Accepted

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 outcome measure(s)

CIN III (cervical intraepithelial neoplasia) lesions — three years
number of CIN III lesions
cervical cancer — three years
number of cervical cancer probes
HPV — three years
number and type of HPV infection of the analyzed probes

Trial sites (1)

Facility	City	Region	Status
Luebeck University, Department for obstetrics and gynecology	Lübeck	Schleswig-Holstein

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02238990 on ClinicalTrials.gov ↗ ← All trials in Germany