NCT05987579

Brief Summary

This study examines tumor- en surgical characteristics of stage T3 cutaneous squamous cell carcinomas on the scalp, diagnosed between 2010 and 2018. Histological data and patient- and tumor characteristics were collected.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 3, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

3.3 years

First QC Date

July 20, 2023

Last Update Submit

April 2, 2025

Conditions

Squamous Cell CarcinomaSurgeryCancer Head Neck

Outcome Measures

Primary Outcomes (3)

  • Surgical characteristics

    Choice of treatment, complications, reconstruction types

    Between 2010-2017

  • Tumor characteristics

    Histological data on invasion depth, tumor differentiation

    Between 2010-2017

  • Patients characteristics

    Risk factors, comorbidities

    Between 2010-2017

Eligibility Criteria

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

Data from patients are collected retrospectively using data from the Pathological Anatomical National Automated Archive (PALGA) of the MUMC+ between 2010 - 2018. The TNM staging of all cutaneous squamous cell carcinomas in the research period was reassessed and classified following the TNM 8 criteria.

You may qualify if:

  • stage T3 cutaneous squamous cell carcinoma of the scalp (histologically proven)
  • surgical treatment or radiotherapy treatment

You may not qualify if:

  • metastasis by diagnosis
  • stage T1/T2/T4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ellen Oyen

Maastricht, Netherlands

Location

Related Publications (1)

  • Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.

    PMID: 28094848BACKGROUND

MeSH Terms

Conditions

Carcinoma, Squamous CellHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellNeoplasms by Site

Study Officials

  • Nicole Kelleners-Smeets, dr.

    Maastricht UMC+

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 14, 2023

Study Start

May 3, 2021

Primary Completion

September 1, 2024

Study Completion

December 1, 2025

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations

NL(1)