TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study

NCT04717739 | Unknown FDA Device

• 1 other identifier: 27.09.2021
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 36

Brief Summary

This non-interventional study aims to investigate change over time in cognitive function, sleep quality, and activity in daily life as important determinants of QoL in a large cohort of GBM patients in Germany treated with TTFields in routine clinical care using low-threshold, electronic PRO and modern automated tracking data analyses. The gained results will allow even better understanding of TTFields therapy in daily life of GBM patients and consequently, better informing patients about what to expect when starting this therapy, increasing therapy compliance in the long-term.

Conditions

Glioblastoma

Keywords

Glioblastoma; GBM; Tumor Treating Fields; TTFields; ePRO

Outcome Measures

Primary Outcomes (5)

• Time of usage of TTFields treatment in follow-up derived from monitoring data of the devices, standardised to usage days, as measure of compliance with TTFields treatment.

  Time of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the Follow-up period

  through study completion, an average of 18 months (mean follow-up time)

• Number of TTFields treatment-related SAEs as assessed by the CEC standardized to one year of FU time

  Number of TTFields treatment-related SAEs standardized to one year of follow-up (FU) is measured using the collection of SAEs during the follow-up period

  through study completion, an average of 18 months (mean follow-up time)

• Changes in daily physical activity as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy

  Changes in daily physical activity will be assessed by smartphone app-based clinical monitoring.

  Up to 4 months after start of TTFields treatment compared to baseline

• Changes in sleep quality as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy

  Changes in sleep quality will be assessed by smartphone app-based clinical monitoring.

  Up to 4 months after start of TTFields treatment compared to baseline

• Changes in neurocognitive functioning as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy.

  Changes in neurocognitive functioning will be assessed by means of MoCA interview tests.

  Up to 4 months after start of TTFields treatment compared to baseline

Study Arms (1)

GBM with indication for TTFields

newly diagnosed GBM with clinical indication for TTFields

Device: TTFields

Interventions

TTFields DEVICE

Tumor Treating Fields (TTFields) help slow down or stop glioblastoma cancer cells from dividing by disrupting dividing mechanism of cancer cells leading to apoptosis. TTFields are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. TTFields are approved for the treatment of newly diagnosed and recurrent GBM.

GBM with indication for TTFields

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed, histologically confirmed GBM and an indication for treatment with NovoTTF-200A System (Optune®) according to IFU and medical guidelines will be enrolled. Patients' written informed consent to use their routine clinical data and app-based monitoring data according to data privacy standards must be obtained prior to documentation of patients' data in the e-CRF.

You may qualify if:

• min.18 years of age
• Newly diagnosed, histologically confirmed GBM
• Patient after completion of radiochemotherapy but within first 3 cycles of first-line tumor-specific maintenance chemotherapy
• Clinical indication of treatment with NovoTTF-200A System (Optune®) according to IFU and medical guidelines
• Signed informed consent

You may not qualify if:

• Any foreseeable deviation from the IFU of NovoTTF-200T Device

Sponsors & Collaborators

• NovoCure Ltd.: lead

Study Sites (36)

Universitätsklinikum Aachen

Aachen, 52074, Germany

ACTIVE NOT RECRUITING

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, 63739, Germany

RECRUITING

Universitätsklinikum Augsburg (AöR)

Augsburg, 86156, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, 53127, Germany

ACTIVE NOT RECRUITING

Klinikum Chemnitz

Chemnitz, 09116, Germany

ACTIVE NOT RECRUITING

Uniklinik Köln

Cologne, 50937, Germany

ACTIVE NOT RECRUITING

Kliniken der Stadt Köln GmbH

Cologne, 51109, Germany

ACTIVE NOT RECRUITING

Carl-Thiem-Klinikum Cottbus

Cottbus, 03048, Germany

RECRUITING

Universitätsklinik Carl Gustav Carus Dresden

Dresden, 01307, Germany

RECRUITING

Sana Kliniken Duisburg

Duisburg, 47055, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Düsseldorf HHU

Düsseldorf, 40225, Germany

ACTIVE NOT RECRUITING

HELIOS Klinikum Erfurt

Erfurt, 99089, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

RECRUITING

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt, 60528, Germany

ACTIVE NOT RECRUITING

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

ACTIVE NOT RECRUITING

BG Klinikum Bergmannstrost Halle

Halle, 06112, Germany

RECRUITING

Onkologische Schwerpunktpraxis Dres. I. Zander und E. von der Heyde

Hanover, 30161, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Jena

Jena, 07747, Germany

ACTIVE NOT RECRUITING

Klinikum Kassel

Kassel, 34125, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum SH Campus Kiel

Kiel, 24105, Germany

RECRUITING

Otto-von-Guericke-Universität Magdeburg

Magdeburg, 39120, Germany

ACTIVE NOT RECRUITING

Med. Fakultät Mannheim der Universität Heidelberg

Mannheim, 68167, Germany

ACTIVE NOT RECRUITING

Johannes Wesling Klinikum Minden

Minden, 32429, Germany

ACTIVE NOT RECRUITING

Kliniken Maria Hilf GmbH

Mönchengladbach, 41063, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, 90471, Germany

ACTIVE NOT RECRUITING

Pius-Hospital Oldenburg

Oldenburg, 26121, Germany

ACTIVE NOT RECRUITING

Niels-Stensen-Kliniken - Marienhospital Osnabrück

Osnabrück, 49076, Germany

SUSPENDED

Universitätsmedizin Rostock

Rostock, 18059, Germany

ACTIVE NOT RECRUITING

HELIOS Kliniken Schwerin GmbH

Schwerin, 19049, Germany

ACTIVE NOT RECRUITING

Johanniter-Krankenhaus Genthin-Stendal GmbH

Stendal, 39576, Germany

RECRUITING

Klinikum Stuttgart

Stuttgart, 70174, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

ACTIVE NOT RECRUITING

Paracelsus-Klinik Zwickau

Zwickau, 08008, Germany

ACTIVE NOT RECRUITING

Related Publications (22)

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  PMID: 26670971 BACKGROUND

• Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718.

  PMID: 29260225 BACKGROUND

• Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

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• Gutin PH, Wong ET. Noninvasive application of alternating electric fields in glioblastoma: a fourth cancer treatment modality. Am Soc Clin Oncol Educ Book. 2012:126-31. doi: 10.14694/EdBook_AM.2012.32.122.

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• Gera N, Yang A, Holtzman TS, Lee SX, Wong ET, Swanson KD. Tumor treating fields perturb the localization of septins and cause aberrant mitotic exit. PLoS One. 2015 May 26;10(5):e0125269. doi: 10.1371/journal.pone.0125269. eCollection 2015.

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MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Martin Glas, Prof.

  University hospital Essen, Essen, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dunja Kosanovic

CONTACT

0049 89 990 1649 968; tigerpro@cri-muc.eu

Study Design

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

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: December 30, 2021
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (36)