Actively Recruiting
The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer (VoiceDetect) - a Feasibility Study
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-07-29
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of voice recordings and fiberendoscopic examinations to monitor patients with laryngeal or hypopharyngeal squamous cell carcinoma (LSCC/HPSCC) who have completed curative treatment, excluding those who had total laryngectomy. The study aims to assess how feasible and well patients comply with regular voice monitoring during follow-up. This observational research will also gather patients' subjective assessments of their vocal problems using the Voice Handicap Index-30 questionnaire (VHI-30). Participants will undergo voice recordings every three months along with an Ear, Nose and Throat (ENT) examination including transnasal fiberendoscopy for at least six months. During each visit, speech samples such as standardized text, vowel sounds, picture descriptions, and specific speech exercises will be recorded. Additionally, patients will complete questionnaires about their health and emotional status. The ENT exam will look for vocal fold mobility issues, lesions, or other abnormalities in the larynx and hypopharynx. During the study, participants will attend regular visits where their voice and throat will be examined, and they will fill out voice-related questionnaires. The research team will track patient adherence to scheduled assessments, subjective and objective voice changes, and any cancer recurrence or new malignancies over a period of up to 21 months. The primary outcomes focus on patients’ compliance with scheduled exams and recordings and the rate of recruitment. This long-term monitoring aims to improve understanding of voice changes and cancer recurrence detection in this patient group.
CONDITIONS
Brief Title
The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed carcinoma in-situ or invasive LSCC or HPSCC
- Age 18 years or older
- Completed treatment with curative intent, any modality
- Clinical confirmation of complete remission through ENT exam including fiberendoscopy within 6 to 30 months after treatment
- Provided informed consent by signing
You will not qualify if you...
- Total laryngectomy as primary therapy
- Any local, regional, or systemic persistence, progression, or recurrence of laryngeal or hypopharyngeal cancer before enrollment
- Tumor persistence, progression, or recurrence in synchronous or metachronous non-laryngeal/-hypopharyngeal malignant tumors within 6 months before enrollment
- Previously treated LSCC/HPSCC or second primary malignancies of the larynx or hypopharynx before the index tumor diagnosis and treatment
- Medical, psychological, familial, sociological, or geographical conditions that may prevent compliance with the study
- Inability to follow study procedures or insufficient knowledge of German or French
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 months
Participants undergo scheduled evaluations including voice recordings, ENT examinations with transnasal fiberendoscopy, and complete questionnaires to detect any recurrence of laryngeal or hypopharyngeal cancer.
Visits every 3 months
Trial Site Locations
Total: 2 locations
1
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University Hospital
Bern, Switzerland, 3010
Actively Recruiting
2
Department of Oto-Rhino-Larnygology, Head and Neck Surgery, University Hospital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
R
Roland Giger, Prof.
M
Miranda Visini, Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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