Clinical trial NCT05894070: The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer
Official title: The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer (VoiceDetect) - a Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Laryngeal Cancer
Hypopharyngeal Cancer
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. 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.).
2. ≥ 18 years of age.
3. 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.
4. 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.
5. Informed consent as documented by signature.

Exclusion Criteria:

1. Total laryngectomy as primary therapy.
2. 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.
3. 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.
4. 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).
5. Presence of any medical, psychological, familial, sociological, or geographical conditions expected to potentially hamper the compliance with the study protocol.
6. Inability to follow procedures (e.g., inability to read) or insufficient knowledge of any project language (German and French).

Primary outcomes:
measure: Patients' compliance with scheduled 3-monthly endoscopic exam, voice recordings, and filling out of questionnaire
timeFrame: 3-18 months
measure: Recruitment rate
timeFrame: 0-18 months
Secondary outcomes:
measure: Subjective changes in voice
timeFrame: 0-18 months
measure: Objective changes in voice 1
timeFrame: 0-18 months
measure: Objective changes in voice 2
timeFrame: 0-18 months
measure: Objective changes in voice 3
timeFrame: 0-18 months
measure: Objective changes in voice 4
timeFrame: 0-18 months
measure: Recurrences of the index tumor
timeFrame: 0-18 months
measure: Recurrences in other localizations
timeFrame: 0-18 months
measure: Second primary malignancies in the larynx/hypopharynx
timeFrame: 0-18 months
measure: Second primary malignancies in other localizations
timeFrame: 0-18 months
measure: Composite of clinical events
timeFrame: 0-18 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University Hospital
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Roland Giger, Prof.
role: PRINCIPAL_INVESTIGATOR
References: