NCT05852665

Brief Summary

The aim of this research is to decrease the number of inadequate tumor-free margins, probably resulting in less adjuvant therapy, less local recurrences and better quality of life.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

April 18, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

April 18, 2023

Last Update Submit

May 1, 2023

Conditions

Buccal Mucosa CancerSquamous Cell Carcinoma

Keywords

Buccal mucosal carcinomaSquamous cell carcinomaUltrasoundMulticenter

Outcome Measures

Primary Outcomes (1)

  • Number of involved margins

    Number of involved margins

    within 2 weeks after surgery

Secondary Outcomes (3)

  • Sensitivity and specificity of ultrasound for identifying involved margins

    within 2 weeks after surgery

  • Number of patients with an indication for local adjuvant therapy

    within one month after surgery

  • Quality of life assessed by questionnaires at 4 timepoints

    before surgery, at 4, 8, and 12 months after surgery

Study Arms (1)

Ultrasound-guided surgery

EXPERIMENTAL
Device: Ultrasound-guided resection

Interventions

Ultrasound-guided resectionDEVICE

Ultrasound-guided resection of buccal squamous cell carcinomas

Ultrasound-guided surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • buccal mucosal squamous cell carcinoma
  • surgical removal under general anesthesia

You may not qualify if:

  • tumor is not visible on ultrasound as echolucent region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Central Study Contacts

Carleen Adriaansens, MSc

CONTACT

088-7567805c.m.e.m.adriaansens-2@umcutrecht.nl

Rob Noorlag

CONTACT

r.noorlag-3@umcutrecht.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 10, 2023

Study Start

September 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share