Evaluation of New Tissue Biomarkers for Cervical Cancer Clinical Trial
Official title:
Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions
| Verified date | May 2022 |
| Source | University of Luebeck |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 100 |
| Est. completion date | December 1, 2030 |
| Est. primary completion date | December 1, 2030 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Luebeck University, Department for obstetrics and gynecology | Luebeck | Schleswig Holstein |
| Lead Sponsor | Collaborator |
|---|---|
| University of Luebeck |
Germany,
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. — View Citation
Gagné 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. Review. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CIN III (cervical intraepithelial neoplasia) lesions | number of CIN III lesions | three years | |
| Primary | cervical cancer | number of cervical cancer probes | three years | |
| Primary | HPV | number and type of HPV infection of the analyzed probes | three years |