Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04753073
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia III Procedure: Non-invasive physical plasma Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Rate of histological complete remission [ Time Frame: 8 Weeks ]
    Rate of histological complete remission of the CIN III at the time of the LEEP excision


Secondary Outcome Measures :
  1. Rate of partial histological remission [ Time Frame: 8 Weeks ]
    Rate of partial histological remission of the CIN I / II

  2. Rate of decreased HPV viral load [ Time Frame: 8 Weeks ]
    Rate of decreased HPV viral load in tissues

  3. Pain and quality of life [ Time Frame: 8 Weeks ]

    Pain and quality of life (Freiburg index for patient satisfaction)

    1. 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
    2. Satisfaction assessment, min/max values: 1-6, higher scores mean worse outcome


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04753073


Contacts
Layout table for location contacts
Contact: Martin Weiss, Dr. med. +497071-29 82211 martin.weiss@med.uni-tuebingen.de
Contact: Melanie Henes, Dr. med +497071-29 82211 melanie.henes@med.uni-tuebingen.de

Locations
Layout table for location information
Germany
University Hospital Tuebingen, Department of Women's Health Recruiting
Tuebingen, Germany, 72076
Contact: Miriam Linneweh, Dr. rer. nat    +4970712982211    miriam.linneweh@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Layout table for investigator information
Principal Investigator: Martin Weiss, Dr. med.q Department of Women's Health, University Hospital Tuebingen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04753073    
Other Study ID Numbers: ZGynO_CIN_III
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type