NCT05497947

Brief Summary

A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

August 10, 2022

Last Update Submit

September 5, 2025

Conditions

Pharyngeal CancerSwallowing DisorderLarynx Cancer

Keywords

SOALpatient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • SOAL- VF

    Patient reported outcome measure

    up to 6 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated by Total PharyngoLaryngectomy in CH Valence

You may qualify if:

  • Total PharyngoLaryngectomy
  • Age ≥ 18 years old
  • Read, write and understand the French language

You may not qualify if:

  • Patient under guardianship, deprived of liberty, safeguard of justice
  • Refusal to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ch Valence

Valence, Drome, 26953, France

Location

MeSH Terms

Conditions

Pharyngeal NeoplasmsDeglutition DisordersLaryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract Neoplasms

Study Officials

  • Guillaume BUIRET, MD

    CH VALENCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 11, 2022

Study Start

July 3, 2021

Primary Completion

July 5, 2022

Study Completion

July 3, 2023

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

FR(1)