Mental Health and Suicidality in Glioblastoma Patients in Germany (SHINE-GLIO)

May 13, 2026 updated by: Sied Kebir, University Hospital, Essen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mareike Rutenkröger, Dr. rer. medic.
  • Phone Number: +4940 7410-56863
  • Email: M.Rutenkroeger@uke.de

Study Locations

  • Germany
      • Berlin, Germany
        • Recruiting
        • Charité
      • Bochum, Germany
        • Not yet recruiting
        • University Hospital Knappschaftskrankenhaus Bochum
      • Essen, Germany, 45147
        • Recruiting
        • University Hospital Essen
      • Hamburg, Germany
        • Recruiting
        • University Hospital Hamburg Eppendorf
      • Heidelberg, Germany
        • Recruiting
        • University Hospital Heidelberg
      • Münster, Germany
        • Recruiting
        • University hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

glioblastoma patients

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
glioblastoma patients
primary disease or recurrence
Diagnostic test: Medical history, physical examination, completing questionnaires, data collection

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicidality
Time Frame: in the last 4 weeks before participating in the study
Measured using a questionnaire
in the last 4 weeks before participating in the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: in the last 2 weeks before participating in the study
Measured using a questionnaire
in the last 2 weeks before participating in the study
Anxiety
Time Frame: in the last 2 weeks before participating in the study
Measured using a questionnaire
in the last 2 weeks before participating in the study
Health-related quality of life (HRQoL)
Time Frame: in the last week before participating in the study
Measured using a questionnaire
in the last week before participating in the study
Social support
Time Frame: at the time of participation in the study (current status queried)
Measured using a questionnaire
at the time of participation in the study (current status queried)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Collaborators

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

Investigators

  • Principal Investigator: Sied Kebir, PD Dr. med., University Hospital, Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-12746-BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical Data from the other study centers will be transferred pseudonymously to the study headquarters in Essen.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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