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RecruitingNCT07409584SHINE-GLIOUpdated Aug 27, 2026

Mental Health and Suicidality in Glioblastoma Patients in Germany

An observational study in Glioblastoma (GBM), sponsored by University Hospital, Essen. Recruiting at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by University Hospital, Essen · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Glioblastoma (GBM)

Keywords

  • glioblastoma
  • suicidality
  • depression
  • observational
03

In context

Glioblastoma

2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.

This study's planned enrollment of 180 is above the median of 60 across 208 observational studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

University Hospital, Essen is the lead sponsor of 118 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

glioblastoma patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Newly diagnosed glioblastoma, IDH wild-type (CNS WHO classification of 2021) after finishing radiotherapy (before first recurrence)
  • Age ≥ 18 years

Exclusion criteria

Exclusion Criteria:

  • Participants with 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.)
  • Recurrent glioblastoma
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • glioblastoma patients

    primary disease or recurrence

    Diagnostic Test: Medical history, physical examination, completing questionnaires, data collection

Interventions

  • Diagnostic testMedical 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

06

What researchers measure

Primary outcomes

  1. Suicidality

    Measured using a questionnaire

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

Secondary outcomes

  1. Depression

    Measured using a questionnaire

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

  2. Anxiety

    Measured using a questionnaire

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

  3. Health-related quality of life (HRQoL)

    Measured using a questionnaire

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

  4. Social support

    Measured using a questionnaire

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

07

Study locations

5 of 6 sites recruiting
08

References and documents

Publications

  • Renovanz M, Hippler M, Kuchen R, Doerner L, Rieger D, Steinbach JP, Ronellenfitsch MW, Voss M, Kessler AF, Nickl V, Misch M, Onken JS, Rapp M, Nadji-Ohl M, Mehlitz M, Meixensberger J, Fehrenbach MK, Keric N, Ringel F, Coburger J, Lucas CW, Wehinger J, Schmidt-Graf F, Gempt J, Tatagiba M, Tabatabai G, Schranz M, Singer S. Physician-led versus questionnaire-based psychosocial screening in adults with high-grade glioma: a cluster-randomized controlled trial (GLIOPT). J Neurooncol. 2025 Dec;175(3):967-977. doi: 10.1007/s11060-025-05223-6. Epub 2025 Sep 10. PubMed 40931258 ↗
  • Costanza A, Zenga F, Ruda R, Amerio A, Aguglia A, Serafini G, Amore M, Bondolfi G, Berardelli I, Nguyen KD. Suicidality in Patients with Brain Tumors: A Brief Literature Review with Clinical Exemplar. Medicina (Kaunas). 2020 Dec 21;56(12):725. doi: 10.3390/medicina56120725. PubMed 33371470 ↗
  • Heinrich M, Hofmann L, Baurecht H, Kreuzer PM, Knuttel H, Leitzmann MF, Seliger C. Suicide risk and mortality among patients with cancer. Nat Med. 2022 Apr;28(4):852-859. doi: 10.1038/s41591-022-01745-y. Epub 2022 Mar 28. PubMed 35347279 ↗
  • Zaorsky NG, Zhang Y, Tuanquin L, Bluethmann SM, Park HS, Chinchilli VM. Suicide among cancer patients. Nat Commun. 2019 Jan 14;10(1):207. doi: 10.1038/s41467-018-08170-1. PubMed 30643135 ↗
  • Dong J, Chen Q, Weng S, Liu L, Wang J, Fang S, Fan X, Jiang T. The effect of depression and anxiety on survival in patients with glioma: a systematic review and meta-analysis. J Neurooncol. 2024 Nov;170(2):265-275. doi: 10.1007/s11060-024-04799-9. Epub 2024 Sep 3. PubMed 39225956 ↗
  • Litofsky NS, Farace E, Anderson F Jr, Meyers CA, Huang W, Laws ER Jr; Glioma Outcomes Project Investigators. Depression in patients with high-grade glioma: results of the Glioma Outcomes Project. Neurosurgery. 2004 Feb;54(2):358-66; discussion 366-7. doi: 10.1227/01.neu.0000103450.94724.a2. PubMed 14744282 ↗
  • Mugge L, Mansour TR, Crippen M, Alam Y, Schroeder J. Depression and glioblastoma, complicated concomitant diseases: a systemic review of published literature. Neurosurg Rev. 2020 Apr;43(2):497-511. doi: 10.1007/s10143-018-1017-2. Epub 2018 Aug 9. PubMed 30094499 ↗
  • Finze A, Deleanu L, Weiss C, Ratliff M, Seiz-Rosenhagen M. Depression in brain tumor patients-early detection and screening. Support Care Cancer. 2023 May 16;31(6):339. doi: 10.1007/s00520-023-07785-5. PubMed 37191815 ↗
  • Piil K, Jarden M, Jakobsen J, Christensen KB, Juhler M. A longitudinal, qualitative and quantitative exploration of daily life and need for rehabilitation among patients with high-grade gliomas and their caregivers. BMJ Open. 2013 Jul 11;3(7):e003183. doi: 10.1136/bmjopen-2013-003183. Print 2013. PubMed 23847270 ↗
  • Goebel S, Stark AM, Kaup L, von Harscher M, Mehdorn HM. Distress in patients with newly diagnosed brain tumours. Psychooncology. 2011 Jun;20(6):623-30. doi: 10.1002/pon.1958. Epub 2011 Mar 30. PubMed 21449043 ↗

Individual participant data

Plan to share: Yes — Clinical Data from the other study centers will be transferred pseudonymously to the study headquarters in Essen.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07409584
Collaborators
University Hospital Muenster, Charite University, Berlin, Germany, University Hospital Heidelberg, Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany, Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sied Kebir (PD Dr. med., University Hospital, Essen) — Principal investigator
First posted
Feb 13, 2026
Start date
Mar 18, 2026
Primary completion
Mar 17, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Christoph Oster, Dr. med.
Contact
christoph.oster@uk-essen.de
+49201-723-82598
Mareike Rutenkröger, Dr. rer. medic.
Contact
M.Rutenkroeger@uke.de
+4940 7410-56863
Sied Kebir, PD Dr. med.
principal investigator · University Hospital, Essen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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