Pharyngeal CancerSOAL-VFNCT05497947
Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy
An observational study of Pharyngeal Cancer and Swallowing Disorder, run by Centre Hospitalier de Valence at 1 site in France.
Trial summary
A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharyngeal Cancer, Swallowing Disorder, Larynx Cancer
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2021to 3 Jul 2023
- 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
- Adult, Older adult
Study population: Patients treated by Total PharyngoLaryngectomy in CH Valence
Who may be able to join
- Total PharyngoLaryngectomy
- Age ≥ 18 years old
- Read, write and understand the French language
Who cannot join
- Patient under guardianship, deprived of liberty, safeguard of justice
- Refusal to participate in research
Trial locations and contacts
1 site in 1 country.
About this study
A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy
Read the detailed description
the SOAL questionnaire is a validated Patient Reported Outcomes (PRO) questionnaire in English language.
The aim of this study is to develop a new tool in french language and to evaluate incidence and the specific impact of swallowing disorders on the quality of life of patients after Total PharyngoLaryngectomy.
- Conditions
- Pharyngeal Cancer, Swallowing Disorder, Larynx Cancer
- Keywords
- SOAL, patient reported outcomes
- Medical subject headings
- Pharyngeal Neoplasms, Deglutition Disorders, Laryngeal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
SOAL- VF
Patient reported outcome measure
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start3 Jul 2021
- Primary completion5 Jul 2022
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharyngeal CancerStudies 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
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valence
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume BUIRET, MD, Principal investigator, CH VALENCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497947
- Sponsor's protocol ID
- RIPH-CHV-05
- Acronym
- SOAL-VF
- Status last verified
- Sep 2025
- First submitted
- 10 Aug 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy
- ClinicalTrials.gov ID
- NCT05497947
- Acronym / sponsor ID
- SOAL-VF / RIPH-CHV-05
- Conditions
- Pharyngeal Cancer, Swallowing Disorder, Larynx Cancer
- Keywords
- SOAL, patient reported outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Centre Hospitalier de ValenceUniversity, hospital or other
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 11 Aug 2022 (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.
A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy
Detailed description
the SOAL questionnaire is a validated Patient Reported Outcomes (PRO) questionnaire in English language.
The aim of this study is to develop a new tool in french language and to evaluate incidence and the specific impact of swallowing disorders on the quality of life of patients after Total PharyngoLaryngectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated by Total PharyngoLaryngectomy in CH Valence
Key inclusion criteria (3 listed)
- Total PharyngoLaryngectomy
- Age ≥ 18 years old
- Read, write and understand the French language
Key exclusion criteria (2 listed)
- Patient under guardianship, deprived of liberty, safeguard of justice
- Refusal to participate in research
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
SOAL- VF
Time frame: up to 6 months
Patient reported outcome measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Guillaume BUIRET, MD principal investigator
CH VALENCE
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 Pharyngeal Cancer and Swallowing Disorder, run by Centre Hospitalier de Valence at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 8 Sep 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SOAL- VF (time frame: up to 6 months). 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 8 Sep 2025.