Laryngeal CancerNCT06784401
Oncologic and Functional Outcome and Quality of Life in Patients Treated for Laryngeal Cancer
An observational study of Laryngeal Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational study is to learn about oncologic and functional outcome and investigate quality of life in patients treated for laryngeal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Cancer
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adults (>= 18 years) of both sexes treated and followed for laryngeal cancer at the Department of Otollaryngology and Audiology of the University Hospital of Bologna.
Who may be able to join
- Patients treated for laryngeal cancer diagnosed by histopathologic examination
Who cannot join
- Patients lost at follow up
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oncologic and Functional Outcome and Quality of Life in Patients Treated for Laryngeal Cancer. (Original Title in Italian Language: "Il Trattamento Del Carcinoma Laringeo: Outcome Oncologico, Funzionale e Quality of Life")
The goal of this observational study is to learn about oncologic and functional outcome and investigate quality of life in patients treated for laryngeal cancer.
Read the detailed description
Adult (>=18 years of age) patients treated by surgery and/or radiation therapy are enrolled retrospectively.
The main question it aims to answer is:
Is voice after total laryngectomy with voice prosthesis better than voice after open partial horizzontal laryngectomy? Subjective and objective scales and parameters are used.
- Conditions
- Laryngeal Cancer
- Medical subject headings
- Laryngeal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncologic and functional outcome in patients treated for laryngeal cancer.
Compare the functional phonatory outcome assessed through objective parameters and subjective scales (GRBAS scale and INFVo Visual Analogue rating Scales) in patients undergoing total laryngectomy with placement of phonatory prosthesis with patients undergoing partial laryngectomy.
Compare the functional phonatory outcome assessed by objective parameters and subjective scales (GRBAS scale and INFVo Visual Analogue rating Scales) in patients undergoing microlaryngoscopy cordectomy with patients undergoing exclusive radiotherapy for glottic cancer.
Identify and describe phonation patterns in patients undergoing laryngectomy partial laryngectomy, evaluating possible associations between phonation patterns and phonatory outcomes.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Quality of life in patients treated for laryngeal cancer.
To compare the quality of life and voice rate of satisfaction by subjective questionnaires (Voice Handicap Index - 10 and I-SECEL) in patients undergoing the different surgical techniques.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Sep 2024
- Primary completion2 Nov 2025 (estimated)
- Study completion1 Dec 2025 (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 IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Botti, MD, PhD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784401
- Sponsor's protocol ID
- LARYNX2023
- Status last verified
- Jan 2024
- First submitted
- 28 Nov 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic and Functional Outcome and Quality of Life in Patients Treated for Laryngeal Cancer. (Original Title in Italian Language: "Il Trattamento Del Carcinoma Laringeo: Outcome Oncologico, Funzionale e Quality of Life")
- ClinicalTrials.gov ID
- NCT06784401
- Acronym / sponsor ID
- LARYNX2023
- Conditions
- Laryngeal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 2 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Jan 2025 (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 goal of this observational study is to learn about oncologic and functional outcome and investigate quality of life in patients treated for laryngeal cancer.
Detailed description
Adult (>=18 years of age) patients treated by surgery and/or radiation therapy are enrolled retrospectively.
The main question it aims to answer is:
Is voice after total laryngectomy with voice prosthesis better than voice after open partial horizzontal laryngectomy? Subjective and objective scales and parameters are used.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (>= 18 years) of both sexes treated and followed for laryngeal cancer at the Department of Otollaryngology and Audiology of the University Hospital of Bologna.
Key inclusion criteria (1 listed)
- Patients treated for laryngeal cancer diagnosed by histopathologic examination
Key exclusion criteria (2 listed)
- Patients lost at follow up
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oncologic and functional outcome in patients treated for laryngeal cancer.
Time frame: through study completion, an average of 1 year
Compare the functional phonatory outcome assessed through objective parameters and subjective scales (GRBAS scale and INFVo Visual Analogue rating Scales) in patients undergoing total laryngectomy with placement of phonatory prosthesis with patients undergoing partial laryngectomy. Compare the functional phonatory outcome assessed by objective parameters and subjective scales (GRBAS scale and INFVo Visual Analogue rating Scales) in patients undergoing microlaryngoscopy cordectomy with patients undergoing exclusive radiotherapy for glottic cancer. Identify and describe phonation patterns in patients undergoing laryngectomy partial laryngectomy, evaluating possible associations between phonation patterns and phonatory outcomes.
1 secondary outcome
Quality of life in patients treated for laryngeal cancer.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
Related trials for Laryngeal Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
RecruitingEarly Phase 1
PET/CT Assessment of Radiation-Induced Vascular Complications in Head and Neck Cancer
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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. This study is not recruiting at the moment.
Cecilia Botti, MD, PhD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site 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, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncologic and functional outcome in patients treated for laryngeal cancer. (time frame: through study completion, an average of 1 year). 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 20 Jan 2025.