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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04753073

Studienbeginn:
Februar 2021

Letztes Update:
28.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms, Carcinoma in Situ, Uterine Cervical Dysplasia

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
-

Studienleiter

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

Kontakt

Martin Weiss, Dr. med.
Kontakt:
Phone: +497071-29 82211
E-Mail: martin.weiss@med.uni-tuebingen.de» Kontaktdaten anzeigen

Melanie Henes, Dr. med
Kontakt:
Phone: +497071-29 82211
E-Mail: melanie.henes@med.uni-tuebingen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Tuebingen, Department of Women's Health
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Miriam Linneweh, Dr. rer. nat
Phone: +4970712982211
E-Mail: miriam.linneweh@med.uni-tuebingen.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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) 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

Studien-Arme

Experimental: NIPP
Treatment of the NIPP group with physical low-temperature plasma, subsequently within 8 weeks LEEP-Exzision
No Intervention: Controll
LEEP-Exzision

Geprüfte Regime

Non-invasive physical plasma:
Treatment with non invasive physical low-temperature plasma

Quelle: ClinicalTrials.gov

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