Cervical Cancer, HPV Infection
Conditions
Brief summary
This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.
Detailed description
The aim of this study is to investigate the HPV (Human papillomavirus)-eradicating efficacy of NIPP (non-invasive physical plasma) in patients with confirmed HPV infection but without cervical dysplasia. Another objective is to examine cellular/molecular/immunological effects of NIPP on the cervix through molecular biological methods following in-vivo treatment. Tissue samples will be obtained at defined intervals via minibiopsy, and analyses will be conducted using molecular biological, histological, and microscopic methods, potentially in collaboration with other research institutes.
Interventions
OTHERCold physical Plasma
The treatment is administered by either the supervising specialists or assistant doctors at the University Women's Hospital, under their supervision and authorization. It's important to note that the NIPP treatment is designed to be relatively brief, with a duration not exceeding 10-20 minutes.
OTHERControl group
A potential natural healing of the HPV infection will be anticipated
Sponsors
University Hospital Tuebingen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria for NIPP treatment * Age ≥ 18 years * mRNA or DNA-based virus detection by smear (also external findings) * Clearly visible transformation zone of the cervix and margins of the lesions corresponding to T1/T2 * Written informed consent to participate in the study * Inclusion criteria for control group * Age ≥ 18 years * Swab-based mRNA or DNA-based virus detection (also external findings) * Clearly visible transformation zone of the cervix corresponding to T1/T2 * Written informed consent to participate in the study
Exclusion criteria
The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV eradication rate | 3-6 months | In the following intervention study, participants will be tested for HPV infection before and after NIPP treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of HPV Genotyping | During the study (12-24 months) | HPV genotyping is crucial for identifying specific viral strains. Correlation studies will be performed via obtained datasets and the application of statistical methods to identify associations among different HPV genotypes. The findings from this study will contribute to our understanding of the virus, guide health interventions, and improve clinical management strategies related to HPV infections. |
| HPV-Quality-of-Life (HPV-QoL) | During the study (12-24 months) | The HPV-Quality-of-Life (HPV-QoL) questionnaire is developed to determine the impact of HPV infection and related interventions on women health-related quality-of-life. |
| Tissue Tolerance and Compatibility of NIPP Treatment | During the study (12-24 months) | Cold plasma generates reactive oxygen and nitrogen species, electric fields, and other biologically active components that can interact with biological tissues. Assessing tissue tolerance and compatibility will be crucial for ensuring the safety and effectiveness of cold plasma treatment. |
| Detection of Intracellular Molecular Plasma Mechanisms | During the study (12-24 months) | The detection of intracellular molecular plasma mechanisms refers to the identification and study of processes and mechanisms that take place within cells through the interaction with so-called plasma, especially cold plasma. The detection of intracellular molecular plasma mechanisms refers to the identification and study of processes that take place within cells through the interaction with plasma, especially cold plasma. Interaction of cold plasma with cellular mechanisms will be studied via routine molecular biological methodology. |
Countries
Germany
Contacts
CONTACTMartin Weiss, Dr. med.
PRINCIPAL_INVESTIGATORMartin Weiss, Dr. med.
University Hospital Tuebingen
Outcome results
None listed