A pilot study to investigate prognostic marker of degeneration from cervical intraepithelial neoplasia to cervix carcinoma

Recruiting

• Conditions: C53; N87; C51; N90; C52; N89; Malignant neoplasm of cervix uteri; Dysplasia of cervix uteri; Malignant neoplasm of vulva; Other noninflammatory disorders of vulva and perineum

• Registration Number: DRKS00024987
• Lead Sponsor: Carl von Ossietzky Universität/Klinikum Oldenburg; Universitätsklinik für Gynäkologie und Geburtshilfe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 550

Inclusion Criteria

Suspicious Pap-result and the patient comes to the dysplasia center of Klinikum Oldenburg for further consultation; abnormal changes in the cervix/vulva/vaginal tissue

Exclusion Criteria

already in chemo-/radiotherapy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We will investigate retrospective the RNA expression level of the following proteins/genes via qRT-PCR: HPV 16 oncogene E6, HPV 16 regulatory gene E2, HPV 18 oncogene E6, HPV 18 regulatory gene E2, APOBEC3A, APOBEC3B, PD-L1, VISTA, Snail, E-cadherin, DNMT1a, DNMT3a, VEGF, EGFR and p53. We will measure the ratio of HPV genes E2/E6 to investigate wether the HPV virus is integrated into the host genome. In addition we will investigate the DNA methylation of 6 marker genes via the GynTect kit and of the HPV 16 and HPV 18 oncogenes via methylation specific qRT-PCR. All experiments will directly start after the positive ethical approvement of our ethical committee and will be performed on our already collected and fixed cervix/vulva/vagina tissue in our biobank.

Secondary Outcome Measures

Name	Time	Method
In addition, the results will be checked on a few frozen cervix/vulva/vagina carcinoma to validate the methods and assays. If they show the same trend as the fixed tissue, we reached the aim, that our results are conform with the situation in patients. For that we will measure the same genes and proteins of the primary outcome via qRT-PCR on cDNA of the frozen tissue. These experiments will start after collecting and freezing all neccessary samples of frozen tissue.