Prognostic Potential of Olfactory Function in Glioblastoma: a Prospective Observational Study

NCT06954636 | Recruiting

• 1 other identifier: 22-10501-BO
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to investigate the prognostic significance of olfactory function in patients with glioblastoma. We are examining olfactory function at various points during therapy and correlating the results with survival data. In addition, neurocognitive tests will be carried out to correlate the results of olfactory function with the patient's cognitive abilities. Investigations into the quality of life and psychological condition of the patients are also performed. In addition to the cohort of glioblastoma patients, there is a control cohort without tumor disease in which the olfactory testing is also carried out in order to have a comparison.

Conditions

Glioblastoma Multiforme, Adult; Glioblastoma or Gliosarcoma; Glioblastoma, Adult

Keywords

olfactory dysfunction; threshold test; identification test; glioblastoma; prognosis; observational study; olfactory function; neurocognition; quality of life

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival in relation to olfactory function

  From enrollment to 2 years after the end of radiotherapy

Secondary Outcomes (4)

• Progression free survival

  From enrollment to 2 years after the end of radiotherapy

• Neurocognition

  From enrollment to 2 years after the end of radiotherapy

• Quality of Life (QoL)

  From enrollment to 2 years after the end of radiotherapy

• Psychological condition

  From enrollment to 2 years after the end of radiotherapy

Study Arms (2)

Newly-diagnosed glioblastoma cohort

Diagnostic Test: olfactory testing (threshold and identification test)

Control cohort

Control group of patients with non-tumourous (neurological) diseases not primarily associated with an olfactory dysfunction

Diagnostic Test: olfactory testing (threshold and identification test)

Interventions

olfactory testing (threshold and identification test) DIAGNOSTIC_TEST

In the identification test, 12 sniffin sticks are presented, which the patient has to name using a selection card with four terms each. Both nostrils are tested individually at each visit during the identification test. A correct answer scores one point. A maximum of 12 points is possible. The threshold test consists of 16 dilution levels. Each level contains one sniffin stick with odor and two blanks. All three sniffin sticks of a dilution level are presented to the patient one after the other with eyes closed. The patient must indicate which of the three sticks contains an odor. Depending on whether the patient gives the correct answer, the three sniffin sticks in the next higher or next lower level are presented next. A maximum of 16 points is possible.

Control cohort; Newly-diagnosed glioblastoma cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly-diagnosed glioblastoma

You may qualify if:

• At least 18 years of age
• Newly-diagnosed glioblastoma (IDH wild-type)
• Never received prior chemotherapy
• Never received radiotherapy to the head or neck before
• KPS ≥ 70
• No history of severe head or brain trauma requiring ICU admission or classified as Glasgow Coma Scale grade 3
• No significant aphasia

You may not qualify if:

• Presence of Neurodegenerative diseases (e.g. Parkinson's disease, Alzheimer's disease, Huntington's disease, Korsakoff's syndrome, Pick's disease, Shy-Drager syndrome)
• History of invasive tumors or surgery in the head or neck area, except for surgeries for non-invasive skin tumors (e.g. basal cell carcinomas)
• Permanent olfactory impairment following infections (e.g., influenza, coronavirus)
• Conditions that, in the examiner's judgment, could interfere with the participant's study compliance (e.g., schizophrenia)
• Language barriers likely to interfere with participation or comprehension of study procedures.

Sponsors & Collaborators

• Sied Kebir: lead
• Münster University Hospital, Germany: collaborator

Study Sites (2)

University Hospital Essen, Department of Neurology, Division of Clinical Neuro-Oncology

Essen, 45147, Germany

RECRUITING

Department of Neurosurgery

Münster, Germany

RECRUITING

Related Publications (5)

• Hummel T, Sekinger B, Wolf SR, Pauli E, Kobal G. 'Sniffin' sticks': olfactory performance assessed by the combined testing of odor identification, odor discrimination and olfactory threshold. Chem Senses. 1997 Feb;22(1):39-52. doi: 10.1093/chemse/22.1.39.

  PMID: 9056084 BACKGROUND

• Hummel T, Konnerth CG, Rosenheim K, Kobal G. Screening of olfactory function with a four-minute odor identification test: reliability, normative data, and investigations in patients with olfactory loss. Ann Otol Rhinol Laryngol. 2001 Oct;110(10):976-81. doi: 10.1177/000348940111001015.

  PMID: 11642433 BACKGROUND

• Kebir S, Hattingen E, Niessen M, Rauschenbach L, Fimmers R, Hummel T, Schafer N, Lazaridis L, Kleinschnitz C, Herrlinger U, Scheffler B, Glas M. Olfactory function as an independent prognostic factor in glioblastoma. Neurology. 2020 Feb 4;94(5):e529-e537. doi: 10.1212/WNL.0000000000008744. Epub 2019 Dec 12.

  PMID: 31831598 BACKGROUND

• Walker IM, Fullard ME, Morley JF, Duda JE. Olfaction as an early marker of Parkinson's disease and Alzheimer's disease. Handb Clin Neurol. 2021;182:317-329. doi: 10.1016/B978-0-12-819973-2.00030-7.

  PMID: 34266602 BACKGROUND

• Oster C, Matyar A, Schmidt T, Hummel T, Hattingen E, Jokisch M, Jokisch D, Grieger J, Cappello G, Kizina K, Lazaridis L, Ahmadipour Y, Rauschenbach L, Stuschke M, Pottgen C, Guberina N, Tertel T, Giebel B, Dreizner GL, Barbato F, Skoda EM, Scheffler B, Muther M, Herrmann K, Kleinschnitz C, Sure U, Deuschl C, Glas M, Kebir S. Decoding glioblastoma survival: unraveling the prognostic potential of olfactory function in a prospective observational study. Neurol Res Pract. 2025 Jul 24;7(1):51. doi: 10.1186/s42466-025-00410-2.

  PMID: 40708059 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

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

Central Study Contacts

Christoph Oster, Dr. med.

CONTACT

+49201-723-82598; christoph.oster@uk-essen.de

Sied Kebir, PD Dr. med.

CONTACT

+49201-723-83133; sied.kebir@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med., Head of Clinical Neuro-Oncology

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 1, 2025
• Study Start: May 3, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)