Glioblastoma (GBM)SHINE-GLIONCT07409584
Mental Health and Suicidality in Glioblastoma Patients in Germany
An observational study of Glioblastoma (GBM), run by University Hospital, Essen at 6 sites in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- Medical history, physical examination, completing questionnaires, data collection
- How many people
- 180 participants
- Where
- 6 sitesGermany
- Study dates
- 18 Mar 2026to 1 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: glioblastoma patients
Who may be able to join
- Newly diagnosed glioblastoma, IDH wild-type (CNS WHO classification of 2021) after finishing radiotherapy (before first recurrence)
- Age ≥ 18 years
Who cannot join
- 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.)
- Recurrent glioblastoma
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Charite
Berlin
- Not yet recruiting
University Hospital Knappschaftskrankenhaus Bochum
Bochum
- Recruiting
University Hospital Essen
Essen, 45147
- Recruiting
University hospital Hamburg Eppendorf
Hamburg
- Recruiting
University hospital Heidelberg
Heidelberg
- Recruiting
University hospital Muenster
Münster
About this study
Official title: 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.
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.
- Conditions
- Glioblastoma (GBM)
- Being tested
- Medical history, physical examination, completing questionnaires, data collection
- Keywords
- glioblastoma, suicidality, depression, observational
- Medical subject headings
- Glioblastoma, Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical history, physical examination, completing questionnaires, data collectionDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| glioblastoma patients | primary disease or recurrence Receives: Diagnostic Test: Medical history, physical examination, completing questionnaires, data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidality
Measured using a questionnaire
Measured: in the last 4 weeks before participating in the study
Secondary outcomes (4)
Depression
Measured using a questionnaire
Measured: in the last 2 weeks before participating in the study
Anxiety
Measured using a questionnaire
Measured: in the last 2 weeks before participating in the study
Health-related quality of life (HRQoL)
Measured using a questionnaire
Measured: in the last week before participating in the study
Social support
Measured using a questionnaire
Measured: at the time of participation in the study (current status queried)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start18 Mar 2026
- Primary completion17 Mar 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Muenster, Charite University, Berlin, Germany, University Hospital Heidelberg, Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Sied Kebir, University Hospital, Essen
- Investigators
- Sied Kebir, PD Dr. med., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409584
- Sponsor's protocol ID
- 25-12746-BO
- Acronym
- SHINE-GLIO
- Status last verified
- Aug 2026
- First submitted
- 3 Feb 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical Data from the other study centers will be transferred pseudonymously to the study headquarters in Essen.
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 40931258Costanza 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 33371470Heinrich 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 35347279Zaorsky 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 30643135Dong 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 39225956Litofsky 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 14744282Mugge 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 30094499Finze 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 37191815Piil 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 23847270Goebel 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