Clinical trial · Observational
Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions
Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Evaluation of New Tissue Biomarkers for Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- CIN III (cervical intraepithelial neoplasia) lesions
- timeFrame
- three years
- description
- number of CIN III lesions
- measure
- cervical cancer
- timeFrame
- three years
- description
- number of cervical cancer probes
- measure
- HPV
- timeFrame
- three years
- description
- number and type of HPV infection of the analyzed probes
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDApgar 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. PMID 19621855
- BACKGROUNDGagne 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. PMID 19061824
- BACKGROUNDMassad 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. PMID 19550210