Using voice recordings to monitor laryngeal and hypopharyngeal cancer recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to monitor patients with laryngeal and hypopharyngeal squamous cell carcinoma who have completed curative treatment, excluding those who underwent total laryngectomy. Participants will provide voice recordings every three months and undergo fiberendoscopic examinations of the larynx and hypopharynx for at least six months. Additionally, patients will complete the Voice Handicap Index-30 questionnaire to assess their vocal problems. The primary goal is to evaluate the feasibility and compliance of long-term voice monitoring in these patients during follow-up.

Why it matters

Who can join: the full rules

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).

Where it's running

• Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University Hospital
  Bern, Switzerland Recruiting
• Department of Oto-Rhino-Larnygology, Head and Neck Surgery, University Hospital Zurich
  Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Roland Giger, Prof. — Inselspital, Bern University Hospital
• Study coordinator: Roland Giger, Prof.
• Email: roland.giger@insel.ch
• Phone: +41 31 632 29 31

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Machine learning helps predict head and neck cancer risk from patient data and images

  Researchers are testing a deep learning model to see if AI can predict the risk of head and neck cancer in adults using clinical data and laryngoscopic images.

  Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07532538

• Study of immune biomarkers in head and neck cancer

  This study is testing if certain immune markers in patients with newly diagnosed head and neck cancer can help predict their treatment outcomes and guide their care.

  Recruiting at 3 sites University of Erlangen-Nürnberg Medical School · Erlangen, Bavaria and 2 other locations · NCT05375266

• A resource for collecting cancer data and biospecimens

  This study is creating a resource to collect health information and samples from cancer patients and healthy individuals to help improve cancer prevention and treatment strategies.

  Recruiting at 42 sites University of Nebraska · Greenwood Village, Colorado and 41 other locations · NCT02012699

• Docetaxel and SX-682 in head and neck cancers and prostate cancer

  This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07667400

• Neoadjuvant chemoimmunotherapy with PD-1 blockade to reduce surgery for advanced head and neck cancer

  This approach will try a short course of chemotherapy plus the PD-1 drug toripalimab before standard treatment for people with advanced head and neck cancers to shrink tumors and allow less extensive surgery or radiation.

  Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT07209189

• Combining targeted radiation with immunotherapy and chemotherapy for advanced laryngeal and hypopharyngeal cancer

  This study is testing a new treatment that combines targeted radiation with immunotherapy and chemotherapy to see if it can help people with advanced laryngeal and hypopharyngeal cancer while preserving their voice box.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT06611137

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.