NCT06805071

Brief Summary

Prospective multicentric study to evaluate decisional regret and psychometric and functional outcomes in patient previously treated with Open Horizontal partial Laryngectomy

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 3, 2025

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

January 28, 2025

Last Update Submit

January 28, 2025

Conditions

Laryngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Decisional Regret Scale

    Evaluation of subjective regret about the therapeutic choice

    From the surgery to the enrollment time (6 months post-treatment)

Secondary Outcomes (4)

  • DASS-21 Questionnaire

    From the surgery to the enrollment time (6 months post-treatment)

  • Chicago Priority Scale

    From the surgery to the enrollment time (6 months post-treatment)

  • VHI-10

    From 6 Months after surgery until the end of the study

  • MD Anderson Dysphagia Inventory

    From 6 Months after surgery until the end of the study

Eligibility Criteria

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

Patients with laryngeal squamous cell carcinoma of any stage amenable of organ preservation surgery.

You may qualify if:

  • SCC larynx treated with OPEN PARTIAL HORIZONTAL LARYNGECTOMY

You may not qualify if:

  • Previous surgical treatment of the larynx
  • Previous CT-RT of the head and neck district

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Matteo Fermi, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Fermi, MD

CONTACT

0512144172matteo.fermi3@unibo.it

Alessandro Rosti, MD

CONTACT

alessandro.rosti3@studio.unibo.it

Study Design

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

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

May 1, 2024

Primary Completion

January 25, 2025

Study Completion

May 31, 2025

Last Updated

February 3, 2025

Record last verified: 2024-05

Locations

IT(1)