Laryngeal CancerVoiceDetectNCT05894070
The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer
An observational study of Laryngeal Cancer and Hypopharyngeal Cancer, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
The investigators will obtain three-monthly voice recordings and fiberendoscopic examinations of the larynx/hypopharynx for a minimal period of 6 months from all laryngeal/hypopharyngeal squamous cell carcinoma (LSCC/HPSCC) patients, who have successfully completed curative primary treatment, except those who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Cancer, Hypopharyngeal Cancer
- What is being tested?
- Voice recording, ENT (Ear, Nose and Throat) examination including transnasal fiberendoscopy, and VHI-30-questionnaire
- How many people
- 100 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 2 Aug 2023to 30 Jun 2026
- 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: The anticipated study population are patients with LSCC and HPSCC who have successfully completed curative, organ-preserving primary treatment and did not show tumor persistence, recurrence, or second primary malignancy prior to the recruitment.
Who may be able to join
- Histopathologically proven carcinoma in-situ or invasive LSCC or HPSCC (in non-surgically treated carcinoma: clinical/radiologic stage I-IV (excluding M1) according to the Union for International Cancer Control (UICC) / Tumor (T), Nodes (N), and Metastases (M) (TNM) 8th ed.; in surgically treated carcinoma: pathological stage I-IV (excluding M1) according to the UICC / TNM 8th ed.).
- ≥ 18 years of age.
- Treatment with curative intent, regardless of treatment modality (mono- or multimodal).
- Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.
- Clinical confirmation of complete remission of LSCC or HPSCC through Ear, Nose and Throat (ENT) examination, including fiberendoscopy of the pharynx and larynx, at the time of enrolment, during the period of eligibility (6 to 30 months after treatment).
- Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.
- Informed consent as documented by signature.
Who cannot join
- Total laryngectomy as primary therapy.
- Any local, regional, and systemic laryngeal or hypopharyngeal cancer persistence/progression, or recurrence before enrolment.
- Excepted: Patients with synchronous laryngeal/hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible.
- Any local, regional, and systemic tumor persistence/progression, or recurrence of synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant tumors within 6 months before enrolment.
- Excepted: Patients with surgically treated progredient or recurrent locally defined Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or non-head and neck progredient or recurrent Tis.
- Any previously treated LSCC/HPSCC or treated second primary malignancies of the larynx or hypopharynx before the diagnosis and treatment of the investigated LSCC/HPSCC (= index tumor).
- Presence of any medical, psychological, familial, sociological, or geographical conditions expected to potentially hamper the compliance with the study protocol.
- Inability to follow procedures (e.g., inability to read) or insufficient knowledge of any project language (German and French).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University Hospital
Bern, 3010
Roland Giger, Prof., +41 31 632 29 31, roland.giger@insel.ch
Miranda Visini, Dr. med., +41 31 632 88 59, miranda.visini@insel.ch
- Recruiting
Department of Oto-Rhino-Larnygology, Head and Neck Surgery, University Hospital Zurich
Zurich, 8091
Simon Müller, Dr. med., +41 44 255 58 50, simon.mueller@usz.ch
Simon Müller, Dr. med.
About this study
Official title: The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer (VoiceDetect) - a Feasibility Study
The investigators will obtain three-monthly voice recordings and fiberendoscopic examinations of the larynx/hypopharynx for a minimal period of 6 months from all laryngeal/hypopharyngeal squamous cell carcinoma (LSCC/HPSCC) patients, who have successfully completed curative primary treatment, except those who underwent total laryngectomy. Furthermore, the investigators will ask the patients to fill out the voice handicap index-30 questionnaire (VHI-30) during each study visit. The VHI-30 allows to make a subjective assessment of the patients' own vocal problem. The primary objective is to assess the feasibility and compliance of longterm regular voice monitoring in LSCC and HPSCC follow-up.
- Conditions
- Laryngeal Cancer, Hypopharyngeal Cancer
- Being tested
- Voice recording, ENT (Ear, Nose and Throat) examination including transnasal fiberendoscopy, and VHI-30-questionnaire
- Medical subject headings
- Laryngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice recording, ENT (Ear, Nose and Throat) examination including transnasal fiberendoscopy, and VHI-30-questionnaireOther
The following speech samples will be recorded from the study participants:
- Standardized, phonetically balanced text
- Sustained, modulated production of five vowels
- Picture description
- Diadochokinetic exercise.
Before starting speech recording, the participant fills in a questionnaire consisting of:
- Health barometer
- Self-rating in terms of stress/fatigue/emotional status.
An Ear, Nose and Throat examination incl. transnasal fiberendoscopy is performed at each visit. The investigators will assess the vocal folds/aryepiglottic folds for the presence of paralysis or reduced mobility, as well as the presence of scar/synechia, edema, erythro-/leukoplakia, or a cancer-suspicious lesion/mass in the larynx/hypopharynx or a chondroradionecrosis in the larynx.
Additionally, it will be assessed, if a tracheotomy canula or a nasogastric tube is in place or was used since the last visit.
Furthermore, the investigators will ask the patients to fill out the VHI-30.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' compliance with scheduled 3-monthly endoscopic exam, voice recordings, and filling out of questionnaire
The number of completed visits/exams out of all scheduled visits/exams.
Measured: 3-21 months
Recruitment rate
Recruitment rate (number of enrolled participants per year).
Measured: 0-21 months
Secondary outcomes (10)
Subjective changes in voice
Subjective changes in voice assessed by the voice handicap index-30 (VHI-30).
Measured: 0-21 months
Objective changes in voice 1
Changes in Roughness - Breathiness - Hoarseness (RBH).
Measured: 0-21 months
Objective changes in voice 2
Changes in Jitter and Shimmer (JS).
Measured: 0-21 months
Objective changes in voice 3
Changes in Glottal-to-Noise Excitation Ratio (GNE).
Measured: 0-21 months
Objective changes in voice 4
Changes in Singing Power Ratio (SPR).
Measured: 0-21 months
Recurrences of the index tumor
Number/Percentage of patients with biopsy-proven local, regional, and/or systemic recurrences of the initially treated LSCC/HPSCC.
Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a recurrence at the multidisciplinary tumor board based on the clinical and/or radiologic findings.
Measured: 0-21 months
Recurrences in other localizations
Number/Percentage of patients with biopsy-proven local, regional, and/or systemic recurrences in other localizations.
Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a recurrence at the multidisciplinary tumor board based on the clinical and/or radiologic findings.
Measured: 0-21 months
Second primary malignancies in the larynx/hypopharynx
Number/Percentage of patients with biopsy-proven local, regional, and/or systemic second primary malignancy in the larynx/hypopharynx.
Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a second primary malignancy at the multidisciplinary tumor board based on the clinical and/or radiologic findings.
Measured: 0-21 months
Second primary malignancies in other localizations
Number/Percentage of patients with biopsy-proven local, regional, and/or systemic second primary malignancy in other localizations.
Note: In special scenarios such as co-morbidities, patient's rejection or other medical conditions, a biopsy can be omitted if there is a consensus for a second primary malignancy at the multidisciplinary tumor board based on the clinical and/or radiologic findings.
Measured: 0-21 months
Composite of clinical events
Composite endpoint: Number/Percentage of patients with laryngeal/hypopharyngeal recurrence, second primary malignancy, edema, scar/synechia, erythro-/leukoplakia, laryngeal chondroradionecrosis and hypomobility/ paralysis determined by fiber-endoscopy.
Measured: 0-21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start2 Aug 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Giger, Prof., Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894070
- Sponsor's protocol ID
- 2023-00838
- Other IDs
- 2023
- Acronym
- VoiceDetect
- Status last verified
- Jul 2025
- First submitted
- 30 May 2023
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer (VoiceDetect) - a Feasibility Study
- ClinicalTrials.gov ID
- NCT05894070
- Acronym / sponsor ID
- VoiceDetect / 2023-00838
- Conditions
- Laryngeal Cancer, Hypopharyngeal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Jun 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.
The investigators will obtain three-monthly voice recordings and fiberendoscopic examinations of the larynx/hypopharynx for a minimal period of 6 months from all laryngeal/hypopharyngeal squamous cell carcinoma (LSCC/HPSCC) patients, who have successfully completed curative primary treatment, except those who underwent total laryngectomy. Furthermore, the investigators will ask the patients to fill out the voice handicap index-30 questionnaire (VHI-30) during each study visit. The VHI-30 allows to make a subjective assessment of the patients' own vocal problem. The primary objective is to assess the feasibility and compliance of longterm regular voice monitoring in LSCC and HPSCC follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The anticipated study population are patients with LSCC and HPSCC who have successfully completed curative, organ-preserving primary treatment and did not show tumor persistence, recurrence, or second primary malignancy prior to the recruitment.
Key inclusion criteria (7 listed)
- Histopathologically proven carcinoma in-situ or invasive LSCC or HPSCC (in non-surgically treated carcinoma: clinical/radiologic stage I-IV (excluding M1) according to the Union for International Cancer Control (UICC) / Tumor (T), Nodes (N), and Metastases (M) (TNM) 8th ed.; in surgically treated carcinoma: pathological stage I-IV (excluding M1) according to the UICC / TNM 8th ed.).
- ≥ 18 years of age.
- Treatment with curative intent, regardless of treatment modality (mono- or multimodal).
- Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.
- Clinical confirmation of complete remission of LSCC or HPSCC through Ear, Nose and Throat (ENT) examination, including fiberendoscopy of the pharynx and larynx, at the time of enrolment, during the period of eligibility (6 to 30 months after treatment).
Key exclusion criteria (8 listed)
- Total laryngectomy as primary therapy.
- Any local, regional, and systemic laryngeal or hypopharyngeal cancer persistence/progression, or recurrence before enrolment.
- Excepted: Patients with synchronous laryngeal/hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible.
- Any local, regional, and systemic tumor persistence/progression, or recurrence of synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant tumors within 6 months before enrolment.
- Excepted: Patients with surgically treated progredient or recurrent locally defined Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or non-head and neck progredient or recurrent Tis.
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 |
|---|---|---|
| Voice recording, ENT (Ear, Nose and Throat) examination including transnasal fiberendoscopy, and VHI-30-questionnaireThe following speech samples will be recorded from the study participants: * Standardized, phonetically balanced text * Sustained, modulated production of five vowels * Picture description * Diadochokinetic exercise. Before starting speech recording, the participant fills in a questionnaire consisting of: * Health barometer * Self-rating in terms of stress/fatigue/emotional status. An Ear, Nose and Throat examination incl. transnasal fiberendoscopy is performed at each visit. The investigators will assess the vocal folds/aryepiglottic folds for the presence of paralysis or reduced mobility, as well as the presence of scar/synechia, edema, erythro-/leukoplakia, or a cancer-suspicious lesion/mass in the larynx/hypopharynx or a chondroradionecrosis in the larynx. Additionally, it will be assessed, if a tracheotomy canula or a nasogastric tube is in place or was used since the last visit. Furthermore, the investigators will ask the patients to fill out the VHI-30. | Other | – |
Primary outcome
Patients' compliance with scheduled 3-monthly endoscopic exam, voice recordings, and filling out of questionnaire
Time frame: 3-21 months
The number of completed visits/exams out of all scheduled visits/exams.
Recruitment rate
Time frame: 0-21 months
Recruitment rate (number of enrolled participants per year).
10 secondary outcomes
Subjective changes in voice
Time frame: 0-21 months
Objective changes in voice 1
Time frame: 0-21 months
Objective changes in voice 2
Time frame: 0-21 months
Objective changes in voice 3
Time frame: 0-21 months
Objective changes in voice 4
Time frame: 0-21 months
Recurrences of the index tumor
Time frame: 0-21 months
Recurrences in other localizations
Time frame: 0-21 months
Second primary malignancies in the larynx/hypopharynx
Time frame: 0-21 months
Second primary malignancies in other localizations
Time frame: 0-21 months
Composite of clinical events
Time frame: 0-21 months
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 29 Jul 2025.
- 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.
Roland Giger, Prof. principal investigator
Inselspital, Bern University Hospital
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 Laryngeal Cancer and Hypopharyngeal Cancer, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 7 inclusion and 8 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 29 Jul 2025. 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 Switzerland. 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 Roland Giger, Prof. (+41 31 632 29 31, roland.giger@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' compliance with scheduled 3-monthly endoscopic exam, voice recordings, and filling out of questionnaire (time frame: 3-21 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2025.