A pilot study to investigate prognostic marker in HPV-induced neoplasia on their way to carcinoma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024987

Enrollment

550

Registered

2021-06-30

Start date

2021-07-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C53 N87 C51 N90 C52 N89

Interventions

Group 1: healthy patient tissue for comparison Group 2: patients with CIN (cervical intraepithelial neoplasia) grade I/ VIN grade I/ VAIN grade I Group 3: patients with CIN (cervical intraepithelial n

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: already in chemo-/radiotherapy

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactMeike Schild-Suhren

Klinikum Oldenburg, Universitätsklinik für Gynäkologie und Geburtshilfe

meike.schild-suhren@klinikum-oldenburg.de0441 4032288

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026