NCT06784401

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

November 28, 2024

Last Update Submit

January 14, 2025

Conditions

Laryngeal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Quality of life in patients treated for laryngeal cancer.

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients treated for laryngeal cancer diagnosed by histopathologic examination

You may not qualify if:

  • Patients lost at follow up
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Study Officials

  • Cecilia Botti, MD, PhD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 28, 2024

First Posted

January 20, 2025

Study Start

September 1, 2024

Primary Completion

November 2, 2025

Study Completion

December 1, 2025

Last Updated

January 20, 2025

Record last verified: 2024-01

Locations

IT(1)