Salivary Gland TumorImmoGlandulaNCT06047236
Immune Biomarker Study for Salivary Gland Carcinoma
An observational study of Salivary Gland Tumor and Benign Salivary Gland Tumor, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
Trial summary
Salivary gland carcinomas (SGC) are rare tumors. The term SGC is not more than an umbrella for a variety of histogenetically, morphologically, and biologically distinct entities. Accordingly, SGCs have not been sufficiently investigated to date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivary Gland Tumor, Benign Salivary Gland Tumor
- What is being tested?
- Sampling
- How many people
- 300 participants
- Where
- 2 sitesGermany
- Study dates
- 8 Jan 2024to 30 Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients presenting for treatment at the participating study centers and meeting the inclusion criteria.
Who may be able to join
- Observational group
- Initial diagnosis of a primary salivary gland carcinoma in the head and neck region (no squamous cell carcinomas)
- Specimen collection from the center of the tumor when the primary tumor is sufficiently large without that the pathological assessment is impaired
- Control group 1
- Initial diagnosis of a benign salivary gland tumor in the head and neck region
- Specimen collection from the center of the tumor when the primary tumor is sufficiently large without that the pathological assessment is impaired
Show all 13Show fewer
- Control group 2
- functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty)
- Specimen collection with sufficiently large resectate during a functional nose surgery
- for all groups:
- Willingness of patients to collect blood, saliva and stool and consent to the preservation of all samples for study purposes.
- Age ≥ 18 years
- sufficient cognitive ability of the patients to understand the purpose of the study and to understand the purpose of the study and agree to it
Who cannot join
- Distant metastasis at the time of diagnosis and simultaneous second cancers, i.e. at study inclusion
- Malignancy in the last 5 years regardless of location (except basal cell carcinoma or cis of the uterine cervix)
- Carcinomas for which specimen collection is not possible or likely without compromising the compromise the pathological evaluation
- Persistent drug or medication abuse
- Patients who are unable or unwilling to comply with protocol and to be treated
- Patients who are represented by a legal guardian
- Patients who are not suitable for participation in the study due to a language barrier
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Erlangen, HNO
Erlangen, Bavaria, 91054
Sarina Mueller, PD, +49-9131-85 ext. 43921, sarina.mueller@uk-erlangen.de
- Recruiting
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Bavaria, 91054
Marlen Haderlein, PD, +49913185 ext. 33968, marlen.haderlein@uk-erlangen.de
About this study
Salivary gland carcinomas (SGC) are rare tumors. The term SGC is not more than an umbrella for a variety of histogenetically, morphologically, and biologically distinct entities. Accordingly, SGCs have not been sufficiently investigated to date. Their rarity makes it challenging to recruit a high number of patients for individual entities in clinical studies, leading to the pooling of patients with different histological subtypes to achieve sufficient participants. The different histological subtypes of SGC exhibit significant differences in their clinicopathological features, including grading, occurrence, and outcome. SGCs usually are stratified into low-, intermediate-, or high-grade tumors. In most kinds of SGC, specific targetable molecular markers are lacking. The inclusion of immunotherapy (IT), however, might improve the outcome of patients suffering from high-grade SGCs. To integrate IT as a therapeutic option for SGC and to facilitate informed therapeutic decisions based on tumor (immune) biology, predictive and prognostic immunological biomarkers are indispensable. In this prospective study, 500 patients will be enrolled, distributed across three arms. The observational cohort includes patients with malignant salivary gland tumors, whereas patients with benign tumors of a salivary gland are grouped in the control group 1. In the control cohort, two patients do not have a salivary gland tumor but have a planned functional surgery of the nose or ear or a maxillofacial surgery. The local immune status of the tumor tissue and the microbiome will be sampled before treatment. In addition, the systemic immune status from peripheral blood will be analyzed before and after surgery and after the adjuvant and definitive chemoradiotherapy (CRT), if applicable. Clinical baseline characteristics and outcome parameters will additionally be collected. Data mining and modeling approaches will be applied to identify interactions between local and systemic immune parameters and to define predictive and prognostic immune signatures based on the evaluated immune markers.
- Conditions
- Salivary Gland Tumor, Benign Salivary Gland Tumor
- Being tested
- Sampling
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingOther
Evaluation of immune characteristics by using patient's stool, saliva, blood, and tumour (not in control group 2) samples.
| Study group | Role | What they receive |
|---|---|---|
| Malignant salivary gland tumor in the head and neck region | Initial diagnosis of primary salivary gland carcinoma in the head and neck region Receives: Other: Sampling | |
| Benign salivary gland tumor in the head and neck region | Initial diagnosis of a benign salivary gland tumor in the head and neck region Receives: Other: Sampling | |
| functional disorders of the nose or ear | Healthy control group. Functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty) without salivary gland tumor. Receives: Other: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
As a primary clinical endpoint, the progression-free survival (PFS) of the patients in the observational cohort will be analyzed after two years.
Measured: 2 years
Secondary outcomes (7)
Locoregional recurrence rate (LRR)
Secondary clinical endpoints, the locoregional recurrence rate (LRR) after two and five years in the observational cohort will be addressed.
Measured: From baseline to the end of study period, up to 5 years
Occurrence of distant metastases
The occurrence of distant metastases after two and five years in the observational cohort will be addressed.
Measured: From baseline to the end of study period, up to 5 years
Longitudinal immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during study period
The distribution of immune cells and messenger substances in the blood will be examined by means of immunophenotyping in order to add the systemic immune cell composition.
Flow cytometric assessment of the amount of circulating immune cell-distribution per milliliter whole blood.
Measured: Change of the immunophenotyping from baseline to the end of study period, up to 5 years
Immune status of the resected tumor
The local immune status of the resected tumor is assessed by examining various immunological parameters during the pathological analysis of the tissue, which includes the expression of immune checkpoint molecules on the cells of the tumor microenvironment, such as PD1, its respective ligands or TIM3 and LAG3. Further, the infiltration of numerous of different immune cell populations in the tumor tissue will be examined, which includes CD19+ CD20+ B cells, CD4+ and CD8+ T cells or neutrophilic granulocytes.
Measured: 1 year
Transcriptional changes in immune cell gene expression
Blood is also drawn into RNA stabilization tubes to create cell lysates for long-term storage and to isolate total RNA from blood cells. Cell pellets from whole blood are preserved for the extraction of nucleic acids. The collection and storage of biomaterials are managed by the Central Biobank Erlangen (CeBE). Transcriptional analyses will be conducted using whole-exome sequencing, RNA sequencing, digital droplet PCR, or real-time quantitative PCR.
Measured: Change of the immunophenotyping from baseline to the end of study period, up to 5 years
Analysis of patient's microbiomic state by examination of saliva, tumor and stool
For the microbiome analysis, stool, saliva, and tumor smear samples are collected preoperatively (stool and saliva) and after the tumor excision (tumor smear). The composition of the oral, bowel, and tumor microbiome is determined through metagenomic analyses to identify all non-human species present in the samples. The qualitative and quantitative diversity of the microbiome is then evaluated using bioinformatics approaches.
Measured: The analyses are conducted from baseline to the end of study period, up to 5 years
Analysis of cytokines and metabolites in peripheral blood and their change at certain points in the course of treatment
Electrochemiluminescent MULTI-ARRAY measurement of concentration (pg/ml whole blood) cytokines/chemoattractant cytokines in the serum/plasma of the patients. Mass spectrometry will be employed to analyze changes in metabolites from the serum and plasma.
Measured: Change of the cytokine expression from baseline to the end of study period, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Jan 2024
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Salivary Gland TumorStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarina Mueller, PD, Study director, Universitätsklinikum Erlangen, HNOMarlen Haderlein, PD, Study director, Universitätsklinikum Erlangen, Radiation OncologyBenjamin Frey, PD, Principal investigator, Universitätsklinikum Erlangen, Radiation Oncology, Translational Radiobiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047236
- Sponsor's protocol ID
- ImmoGlandula
- Acronym
- ImmoGlandula
- Status last verified
- Dec 2025
- First submitted
- 14 Sep 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donaubauer AJ, Ruhle PF, Becker I, Fietkau R, Gaipl US, Frey B. One-Tube Multicolor Flow Cytometry Assay (OTMA) for Comprehensive Immunophenotyping of Peripheral Blood. Methods Mol Biol. 2019;1904:189-212. doi: 10.1007/978-1-4939-8958-4_8.
PubMed 30539471Donaubauer AJ, Becker I, Ruhle PF, Fietkau R, Gaipl US, Frey B. Analysis of the immune status from peripheral whole blood with a single-tube multicolor flow cytometry assay. Methods Enzymol. 2020;632:389-415. doi: 10.1016/bs.mie.2019.03.003. Epub 2019 Apr 4.
PubMed 32000906Zhou JG, Donaubauer AJ, Frey B, Becker I, Rutzner S, Eckstein M, Sun R, Ma H, Schubert P, Schweizer C, Fietkau R, Deutsch E, Gaipl U, Hecht M. Prospective development and validation of a liquid immune profile-based signature (LIPS) to predict response of patients with recurrent/metastatic cancer to immune checkpoint inhibitors. J Immunother Cancer. 2021 Feb;9(2):e001845. doi: 10.1136/jitc-2020-001845.
PubMed 33593828Hiss S, Eckstein M, Segschneider P, Mantsopoulos K, Iro H, Hartmann A, Agaimy A, Haller F, Mueller SK. Tumour-Infiltrating Lymphocytes (TILs) and PD-L1 Expression Correlate with Lymph Node Metastasis, High-Grade Transformation and Shorter Metastasis-Free Survival in Patients with Acinic Cell Carcinoma (AciCC) of the Salivary Glands. Cancers (Basel). 2021 Feb 25;13(5):965. doi: 10.3390/cancers13050965.
PubMed 33669038Freitag V, Lettmaier S, Semrau S, Hecht M, Mantsopoulos K, Muller SK, Traxdorf M, Iro H, Agaimy A, Fietkau R, Haderlein M. High-grade salivary gland cancer: is surgery followed by radiotherapy an adequate treatment to reach tumor control? Results from a tertiary referral centre focussing on incidence and management of distant metastases. Eur Arch Otorhinolaryngol. 2022 May;279(5):2553-2563. doi: 10.1007/s00405-021-07024-9. Epub 2021 Aug 26.
PubMed 34436631Haderlein M, Scherl C, Semrau S, Lettmaier S, Uter W, Neukam FW, Iro H, Agaimy A, Fietkau R. High-grade histology as predictor of early distant metastases and decreased disease-free survival in salivary gland cancer irrespective of tumor subtype. Head Neck. 2016 Apr;38 Suppl 1:E2041-8. doi: 10.1002/hed.24375. Epub 2016 Feb 3.
PubMed 26841273Donaubauer AJ, Frey B, Agaimy A, Lange F, Mogge L, Fietkau R, Iro H, Munoz LE, Weber M, Kesting M, Gaipl US, Haderlein M, Muller S. Definition of predictive and prognostic immune biomarkers for salivary gland cancer from the intratumoural and systemic immune status: detailed protocol of the prospective, observatory ImmoGlandula study. BMJ Open. 2026 Jan 12;16(1):e100021. doi: 10.1136/bmjopen-2025-100021.
PubMed 41526019
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Biomarker Study for Salivary Gland Carcinoma
- ClinicalTrials.gov ID
- NCT06047236
- Acronym / sponsor ID
- ImmoGlandula / ImmoGlandula
- Conditions
- Salivary Gland Tumor, Benign Salivary Gland Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Salivary gland carcinomas (SGC) are rare tumors. The term SGC is not more than an umbrella for a variety of histogenetically, morphologically, and biologically distinct entities. Accordingly, SGCs have not been sufficiently investigated to date. Their rarity makes it challenging to recruit a high number of patients for individual entities in clinical studies, leading to the pooling of patients with different histological subtypes to achieve sufficient participants. The different histological subtypes of SGC exhibit significant differences in their clinicopathological features, including grading, occurrence, and outcome. SGCs usually are stratified into low-, intermediate-, or high-grade tumors. In most kinds of SGC, specific targetable molecular markers are lacking. The inclusion of immunotherapy (IT), however, might improve the outcome of patients suffering from high-grade SGCs. To integrate IT as a therapeutic option for SGC and to facilitate informed therapeutic decisions based on tumor (immune) biology, predictive and prognostic immunological biomarkers are indispensable. In this prospective study, 500 patients will be enrolled, distributed across three arms. The observational cohort includes patients with malignant salivary gland tumors, whereas patients with benign tumors of a salivary gland are grouped in the control group 1. In the control cohort, two patients do not have a salivary gland tumor but have a planned functional surgery of the nose or ear or a maxillofacial surgery. The local immune status of the tumor tissue and the microbiome will be sampled before treatment. In addition, the systemic immune status from peripheral blood will be analyzed before and after surgery and after the adjuvant and definitive chemoradiotherapy (CRT), if applicable. Clinical baseline characteristics and outcome parameters will additionally be collected. Data mining and modeling approaches will be applied to identify interactions between local and systemic immune parameters and to define predictive and prognostic immune signatures based on the evaluated immune markers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Malignant salivary gland tumor in the head and neck region | – | Other: SamplingInitial diagnosis of primary salivary gland carcinoma in the head and neck region |
| Benign salivary gland tumor in the head and neck region | – | Other: SamplingInitial diagnosis of a benign salivary gland tumor in the head and neck region |
| functional disorders of the nose or ear | – | Other: SamplingHealthy control group. Functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty) without salivary gland tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for treatment at the participating study centers and meeting the inclusion criteria.
Key inclusion criteria (13 listed)
- Observational group
- Control group 1
- Control group 2
- Willingness of patients to collect blood, saliva and stool and consent to the preservation of all samples for study purposes.
- Age ≥ 18 years
Key exclusion criteria (7 listed)
- Distant metastasis at the time of diagnosis and simultaneous second cancers, i.e. at study inclusion
- Malignancy in the last 5 years regardless of location (except basal cell carcinoma or cis of the uterine cervix)
- Carcinomas for which specimen collection is not possible or likely without compromising the compromise the pathological evaluation
- Persistent drug or medication abuse
- Patients who are unable or unwilling to comply with protocol and to be treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamplingEvaluation of immune characteristics by using patient's stool, saliva, blood, and tumour (not in control group 2) samples. | Other | Benign salivary gland tumor in the head and neck region, Malignant salivary gland tumor in the head and neck region, functional disorders of the nose or ear |
Primary outcome
Progression-free survival (PFS)
Time frame: 2 years
As a primary clinical endpoint, the progression-free survival (PFS) of the patients in the observational cohort will be analyzed after two years.
7 secondary outcomes
Locoregional recurrence rate (LRR)
Time frame: From baseline to the end of study period, up to 5 years
Occurrence of distant metastases
Time frame: From baseline to the end of study period, up to 5 years
Longitudinal immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during study period
Time frame: Change of the immunophenotyping from baseline to the end of study period, up to 5 years
Immune status of the resected tumor
Time frame: 1 year
Transcriptional changes in immune cell gene expression
Time frame: Change of the immunophenotyping from baseline to the end of study period, up to 5 years
Analysis of patient's microbiomic state by examination of saliva, tumor and stool
Time frame: The analyses are conducted from baseline to the end of study period, up to 5 years
Analysis of cytokines and metabolites in peripheral blood and their change at certain points in the course of treatment
Time frame: Change of the cytokine expression from baseline to the end of study period, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 30539471Donaubauer AJ, Ruhle PF, Becker I, Fietkau R, Gaipl US, Frey B. One-Tube Multicolor Flow Cytometry Assay (OTMA) for Comprehensive Immunophenotyping of Peripheral Blood. Methods Mol Biol. 2019;1904:189-212. doi: 10.1007/978-1-4939-8958-4_8.
- Results publication: PubMed 32000906Donaubauer AJ, Becker I, Ruhle PF, Fietkau R, Gaipl US, Frey B. Analysis of the immune status from peripheral whole blood with a single-tube multicolor flow cytometry assay. Methods Enzymol. 2020;632:389-415. doi: 10.1016/bs.mie.2019.03.003. Epub 2019 Apr 4.
- Results publication: PubMed 33593828Zhou JG, Donaubauer AJ, Frey B, Becker I, Rutzner S, Eckstein M, Sun R, Ma H, Schubert P, Schweizer C, Fietkau R, Deutsch E, Gaipl U, Hecht M. Prospective development and validation of a liquid immune profile-based signature (LIPS) to predict response of patients with recurrent/metastatic cancer to immune checkpoint inhibitors. J Immunother Cancer. 2021 Feb;9(2):e001845. doi: 10.1136/jitc-2020-001845.
- Results publication: PubMed 33669038Hiss S, Eckstein M, Segschneider P, Mantsopoulos K, Iro H, Hartmann A, Agaimy A, Haller F, Mueller SK. Tumour-Infiltrating Lymphocytes (TILs) and PD-L1 Expression Correlate with Lymph Node Metastasis, High-Grade Transformation and Shorter Metastasis-Free Survival in Patients with Acinic Cell Carcinoma (AciCC) of the Salivary Glands. Cancers (Basel). 2021 Feb 25;13(5):965. doi: 10.3390/cancers13050965.
- Results publication: PubMed 34436631Freitag V, Lettmaier S, Semrau S, Hecht M, Mantsopoulos K, Muller SK, Traxdorf M, Iro H, Agaimy A, Fietkau R, Haderlein M. High-grade salivary gland cancer: is surgery followed by radiotherapy an adequate treatment to reach tumor control? Results from a tertiary referral centre focussing on incidence and management of distant metastases. Eur Arch Otorhinolaryngol. 2022 May;279(5):2553-2563. doi: 10.1007/s00405-021-07024-9. Epub 2021 Aug 26.
- Results publication: PubMed 26841273Haderlein M, Scherl C, Semrau S, Lettmaier S, Uter W, Neukam FW, Iro H, Agaimy A, Fietkau R. High-grade histology as predictor of early distant metastases and decreased disease-free survival in salivary gland cancer irrespective of tumor subtype. Head Neck. 2016 Apr;38 Suppl 1:E2041-8. doi: 10.1002/hed.24375. Epub 2016 Feb 3.
- Derived from this study: PubMed 41526019Donaubauer AJ, Frey B, Agaimy A, Lange F, Mogge L, Fietkau R, Iro H, Munoz LE, Weber M, Kesting M, Gaipl US, Haderlein M, Muller S. Definition of predictive and prognostic immune biomarkers for salivary gland cancer from the intratumoural and systemic immune status: detailed protocol of the prospective, observatory ImmoGlandula study. BMJ Open. 2026 Jan 12;16(1):e100021. doi: 10.1136/bmjopen-2025-100021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarina Mueller, PD study director
Universitätsklinikum Erlangen, HNO
Marlen Haderlein, PD study director
Universitätsklinikum Erlangen, Radiation Oncology
Benjamin Frey, PD principal investigator
Universitätsklinikum Erlangen, Radiation Oncology, Translational Radiobiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Gland Tumor and Benign Salivary Gland Tumor, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Studiensekretariat (+49913185 ext. 43921, studiensekretariat.ST@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06047236, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.