NCT05538806

Brief Summary

The purpose of this post-authorisation medical device study is to obtain real life data on the use of Tumor Treating Fields (TTFields) in patients with pleural mesothelioma in routine clinical care. Patients with pleural mesothelioma and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
3 countries

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Aug 2023Jun 2028

First Submitted

Initial submission to the registry

September 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

August 22, 2025

Status Verified

December 1, 2024

Enrollment Period

4.3 years

First QC Date

September 6, 2022

Last Update Submit

August 18, 2025

Conditions

Pleural Mesothelioma

Keywords

Pleural MesotheliomaTTFields

Outcome Measures

Primary Outcomes (1)

  • Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.

    54 Months

Secondary Outcomes (2)

  • Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences.

    3 years + 18 months follow up

  • Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy.

    QoL will be assessed at baseline, 3 and 6 months.

Study Arms (1)

Group 1

all patients will receive routine clinical care and TTFields

Device: TTFields

Interventions

TTFieldsDEVICE

all patients will receive routine clinical care and TTFields

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult, histologically confirmed pleural mesothelioma without any option of curative resection

You may qualify if:

  • ≥ 18 years of age
  • Histologically confirmed pleural mesothelioma without any option of curative resection
  • Planned treatment with NovoTTF-200T System according to IFU and medical guidelines
  • Life expectancy more than 3 months at day of enrollment
  • Signed informed consent for use and processing of data

You may not qualify if:

  • Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Lungenklinik Gauting

Gauting, Bavaria, 82131, Germany

RECRUITING

University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

Klinikum Bremen-Ost

Bremen, City state Bremen, 28325, Germany

RECRUITING

Asklepios Klinikum Harburg

Harburg, Hamburg, 21075, Germany

RECRUITING

University Medicine Göttingen

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

University Hospital Carl Gustav Carus Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Lungenklinik Heckeshorn

Berlin, 14165, Germany

RECRUITING

Kliniken der Stadt Koeln

Cologne, 51109, Germany

RECRUITING

Florence-Nightingale-Hospital

Düsseldorf, 40489, Germany

RECRUITING

Klinikum Essen-Mitte

Essen, 45136, Germany

RECRUITING

University Hospital Essen

Essen, 45147, Germany

RECRUITING

Niels-Stensen Hospital

Georgsmarienhütte, 49124, Germany

RECRUITING

Krankenhaus Martha-Maria Halle-Doelau

Halle, 06120, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Lungenklinik Hemer

Hemer, 58675, Germany

RECRUITING

Evangelisches Krankenhaus Herne

Herne, 44623, Germany

RECRUITING

Krankenhaus Bethanien Moers

Moers, 47441, Germany

RECRUITING

GEHO Muenster

Münster, 48153, Germany

RECRUITING

Fachkliniken Wangen

Wangen, 88239, Germany

RECRUITING

Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo"

Alessandria, Italy

RECRUITING

Humanitas Gavazzeni

Bergamo, Italy

RECRUITING

Erasmus MC Cancer Centre

Rotterdam, 3015, Netherlands

RECRUITING

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Giovanni Ceresoli

CONTACT

+392 9626717giovanni.ceresoli@mc.humanitas.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 14, 2022

Study Start

August 1, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

August 22, 2025

Record last verified: 2024-12

Locations

NL(1)IT(2)DE(20)