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NCT Number: NCT07409584

Mental Health and Suicidality in Glioblastoma Patients in Germany

The aim of the study is to use standardized questionnaires to systematically record influencing factors or predictors for suicidal behavior in glioblastoma patients, particularly with regard to existing depression and anxiety symptoms.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite, Berlin, Germany

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About this study

Treatment will be provided in accordance with guidelines as part of the study. If a patient decides to participate in the study and have given consent, he/she will undergo a study visit. In addition to a consultation with a physician ("medical history"), this includes a physical examination and the completion of questionnaires (Patient Health Questionnaire-8 to assess depression, Generalized Anxiety Disorder-7 to assess anxiety, Scale of Suicidal Experiences and Behavior to assess suicidality, EORTC-QLQ-30, and EORTC-QLQ BN-20 to assess health-related quality of life, and a short questionnaire on social support for chronic illnesses). If a need for psycho-oncological treatment is identified during the consultation (or during the examination itself) or expressed by the patient, a referral to the relevant specialist department will be arranged (if this has not already been done). Patient data used in the study is taken from the medical record (master data, diagnosis, therapy, MRIs, etc.) and from the study visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of glioblastoma, IDH wild-type (CNS WHO classification of 2021)
  • Age ≥ 18 years

Exclusion criteria

  • Participants with clinically significant aphasia or language barrier as assessed by the investigator
  • History of other malignant tumors
  • Known tumor predisposition syndrome (e.g., Li-Fraumeni syndrome, Cowden syndrome, etc.)

Treatment and study plan

Medical history, physical examination, completing questionnaires, data collection

Diagnostic Test

Medical history Physical examination

Completion of validated questionnaires:

  • Suicide Scale (SSEV)
  • Patient Health Questionnaire-8 (PHQ-8)
  • Generalized Anxiety Disorder-7 (GAD-7)
  • EORTC-QLQ-30
  • EORTC-QLQ-BN-20
  • Short questionnaire on social support for chronic illnesses (SUCE-4) Data collection from medical records

Primary outcomes

  1. Suicidality

    Time frame: in the last 4 weeks before participating in the study

    Measured using a questionnaire

Secondary outcomes

  1. Depression

    Time frame: in the last 2 weeks before participating in the study

    Measured using a questionnaire

  2. Anxiety

    Time frame: in the last 2 weeks before participating in the study

    Measured using a questionnaire

  3. Health-related quality of life (HRQoL)

    Time frame: in the last week before participating in the study

    Measured using a questionnaire

  4. Social support

    Time frame: at the time of participation in the study (current status queried)

    Measured using a questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph Oster, Dr. med.

CONTACT

[email protected]

+49201-723-82598

Mareike Rutenkröger, Dr. rer. medic.

CONTACT

[email protected]

+4940 7410-56863

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Collaborators

  • Charite University, Berlin, Germany
  • Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany
  • University Hospital Heidelberg
  • University Hospital Muenster
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study title

Mental Health and Suicidality in Glioblastoma Patients in Germany - a Multicenter Observational Study (SHINE-GLIO Study)

Acronym: SHINE-GLIO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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