Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma (ZGynO_CINIII)

The aim of the prospective, unicenter proof-of-principle study is to investigate the anti-neoplastic effectiveness of NIPP against CIN III lesions.

• The aim of this project is to evaluate the potential of a previous NIPP treatment to significantly reduce the invasiveness of the LEEP excision.
• Another aim of this study is to investigate cellular / molecular effects of NIPP following the in-vivo treatment of the cervix using molecular biological methods. For this purpose, tissue treated with plasma is taken after defined periods of time by mini biopsy and examined using molecular biological, histological and microscopic methods.

Study Overview

• Status: Completed
• Conditions: Cervical Intraepithelial Neoplasia III
• Intervention / Treatment: Procedure: Non-invasive physical plasma

Detailed Description

Cervical intraepithelial neoplasms (CIN), classified into severity levels CIN I to III, can be precursors to cervical cancer (CC), the world's third most common cancer in women (270,000 deaths / year), which radical therapies are often associated with lifelong severe physical and emotional stress. Cross-sectional studies found a prevalence for CIN of 62 per 1,000 women and incidences of 1.2 (CIN I), 0.8 (CIN II) and 0.7 (CIN III) per 1,000 women per year (highest incidence of CIN between 20 and 24 years) age). The standard therapy for the treatment of CIN III by LEEP excision is associated with an increase in mortality of 17%. CIN III, in particular, is associated with a significant decline in quality of life, psychological well-being and sexual health, although on average only about 12% of CIN III lesions progress to invasive CC. The resulting over-treatment (in around 8-9 out of 10 patients) with invasive procedures is a serious problem for affected women, health care providers and the health economy.

The NIPP treatment is a tissue-sparing, pain-free, easy to carry out and outpatient treatment method without anesthesia and hospitalization. A non-randomized, one-arm feasibility study at the Department of Women's Health (649 / 2017BO1) already showed the effectiveness of a NIPP treatment.

Clinical implications for CIN III:

• A previous NIPP treatment should significantly reduce the invasiveness of the LEEP excision.
• If the oncological safety of NIPP treatment is comparable (histological complete remission of CIN III), NIPP is to be established as a safe alternative to LEEP excision in the future.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • University Hospital Tuebingen, Department of Women's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years

  • Histologically confirmed CIN III
  • Clearly visible transformation zone of the portio and margins of the lesions according to T1 / T2
  • signed written consent

Exclusion Criteria:

• Not fully visible transformation zone

  • Indication of an invasive disease
  • Serious cardiovascular diseases
  • Patients who only want to undergo a LEEP excision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NIPP; Treatment of the NIPP group with physical low-temperature plasma, subsequently within 8 weeks LEEP-Exzision	Procedure: Non-invasive physical plasma; Treatment with non invasive physical low-temperature plasma
No Intervention: Controll; LEEP-Exzision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of histological complete remission	Rate of histological complete remission of the CIN III at the time of the LEEP excision	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of partial histological remission	Rate of partial histological remission of the CIN I / II	8 Weeks
Rate of decreased HPV viral load	Rate of decreased HPV viral load in tissues	8 Weeks
Pain and quality of life	Pain and quality of life (Freiburg index for patient satisfaction); Pain assessment i) previous to, ii) during, iii) 4 h after, iv) 2 days after, v) 1 week after NIPP treatment, min/max values: 0 - 10, higher scores mean worse outcome; Satisfaction assessment, min/max values: 1-6, higher scores mean worse outcome	8 Weeks

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Martin Weiss, Dr. med.q, Department of Women's Health, University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
• Other Study ID Numbers: ZGynO_CIN_III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No