Laryngeal Squamous Cell CarcinomaNCT06805071
Decisional Regret in Open Partial Horizontal Laryngectomy
An observational study of Laryngeal Squamous Cell Carcinoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Prospective multicentric study to evaluate decisional regret and psychometric and functional outcomes in patient previously treated with Open Horizontal partial Laryngectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Squamous Cell Carcinoma
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 31 May 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: Patients with laryngeal squamous cell carcinoma of any stage amenable of organ preservation surgery.
Who may be able to join
- SCC larynx treated with OPEN PARTIAL HORIZONTAL LARYNGECTOMY
Who cannot join
- Previous surgical treatment of the larynx
- Previous CT-RT of the head and neck district
Trial locations and contacts
1 site in 1 country.
Alessandro Rosti, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40138
ALESSANDRO ROSTI, PhD, MD, +393462245614, alessandro.rosti3@studio.unibo.it
Matteo Fermi, MD
About this study
Prospective multicentric study to evaluate decisional regret and psychometric and functional outcomes in patient previously treated with Open Horizontal partial Laryngectomy
- Conditions
- Laryngeal Squamous Cell Carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Regret Scale
Evaluation of subjective regret about the therapeutic choice
Measured: From the surgery to the enrollment time (6 months post-treatment)
Secondary outcomes (4)
DASS-21 Questionnaire
21 items-questionnaire about depression, anxiety and stress during the post-treatment period
Measured: From the surgery to the enrollment time (6 months post-treatment)
Chicago Priority Scale
12 items-ranking of Oncological therapeutic objectives of the Head and Neck patient
Measured: From the surgery to the enrollment time (6 months post-treatment)
VHI-10
Self evaluation of the dysphonia after surgery
Measured: From 6 Months after surgery until the end of the study
MD Anderson Dysphagia Inventory
Self evaluation of dysphagia post surgical treatment + adjuvant therapy if administered
Measured: From 6 Months after surgery until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 May 2024
- Primary completion25 Jan 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Fermi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805071
- Sponsor's protocol ID
- DROPHL-2023
- Status last verified
- May 2024
- First submitted
- 28 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decisional Regret in Open Partial Horizontal Laryngectomy
- ClinicalTrials.gov ID
- NCT06805071
- Acronym / sponsor ID
- DROPHL-2023
- Conditions
- Laryngeal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 25 Jan 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 3 Feb 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.
Prospective multicentric study to evaluate decisional regret and psychometric and functional outcomes in patient previously treated with Open Horizontal partial Laryngectomy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with laryngeal squamous cell carcinoma of any stage amenable of organ preservation surgery.
Key inclusion criteria (1 listed)
- SCC larynx treated with OPEN PARTIAL HORIZONTAL LARYNGECTOMY
Key exclusion criteria (2 listed)
- Previous surgical treatment of the larynx
- Previous CT-RT of the head and neck district
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
Decisional Regret Scale
Time frame: From the surgery to the enrollment time (6 months post-treatment)
Evaluation of subjective regret about the therapeutic choice
4 secondary outcomes
DASS-21 Questionnaire
Time frame: From the surgery to the enrollment time (6 months post-treatment)
Chicago Priority Scale
Time frame: From the surgery to the enrollment time (6 months post-treatment)
VHI-10
Time frame: From 6 Months after surgery until the end of the study
MD Anderson Dysphagia Inventory
Time frame: From 6 Months after surgery until the end of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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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.
Alessandro Rosti, MD contact
Matteo Fermi, MD 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 Squamous Cell Carcinoma, 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 3 Feb 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?
Contact Matteo Fermi, MD (0512144172, matteo.fermi3@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Regret Scale (time frame: From the surgery to the enrollment time (6 months post-treatment)). 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 3 Feb 2025.