Clinical trial NCT06291311: Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants
Official title: Treatment of Infections of the Cervix Uteri With High- and Low-risk Variants of the Human Papillomavirus Using Non-invasive Physical Plasma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV Infection
Cervical Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study includes patients aged 18 and over from the dysplasia clinic of the University Women's Hospital Tübingen who have been diagnosed with an infection of the cervix uteri involving both high- and low-risk HPV viruses.

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.

Eligibility criteria: 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 exclusion criteria apply to both groups of patients (NIPP treatment and control group).

* Transformation zone not fully visible
* Evidence of invasive disease
* Serious cardiovascular diseases

Primary outcomes:
measure: HPV eradication rate
timeFrame: 3-6 months
Secondary outcomes:
measure: Correlation of HPV Genotyping
timeFrame: During the study (12-24 months)
measure: HPV-Quality-of-Life (HPV-QoL)
timeFrame: During the study (12-24 months)
measure: Tissue Tolerance and Compatibility of NIPP Treatment
timeFrame: During the study (12-24 months)
measure: Detection of Intracellular Molecular Plasma Mechanisms
timeFrame: During the study (12-24 months)
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Department of Women's Health
Study officials:
affiliation: University Hospital Tuebingen
name: Martin Weiss, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: