The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · May 30, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how voice recordings can help detect if laryngeal (voice box) and hypopharyngeal (the area behind the throat) cancers come back after treatment. The study involves patients who have been successfully treated for these types of cancer, but not those who had their voice box completely removed. Participants will have their voices recorded every three months and will also undergo checks of their throat and voice box using a special camera. Additionally, they will fill out a questionnaire that helps assess how their voice problems affect their daily lives. The main goal is to see if regularly monitoring voice changes can be a helpful follow-up tool for patients recovering from these cancers.

To be eligible for this trial, participants should be at least 18 years old and must have had a confirmed diagnosis of laryngeal or hypopharyngeal cancer that has been successfully treated. They should show no signs of cancer returning at the time of enrollment. Patients who have had other types of cancer or treatments are also considered, as long as they are in complete remission and their cancer hasn’t returned in the past six months. Those who join can expect to participate in regular voice recordings and health checks over a period of at least six months, providing valuable data that could improve follow-up care for future patients.

Gender

ALL

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).