Clinical trial NCT05987579: Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp
Official title: Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Squamous Cell Carcinoma
Surgery
Cancer Head Neck
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: Cutaneous squamous cell carcinoma is the second most common type of non-melanoma skin cancer, following basal cell carcinoma. Following the American Joint Committee on Cancer Tumour, Node and Metastasis (TNM) Classification of Malignant Tumors staging system (TNM8), T3 cutaneous squamous cell carcinomas comprise an interesting group, especially on the scalp, because of the thin subcutaneous fat layer. According to the TNM8 criteria, T3 include all cutaneous squamous cel carcinomas with greatest tumor dimension ≥4cm, tumors with minimal bone erosion or perineural growth (defined as involvement of the nerve sheath of a nerve lying deeper than the dermis or measuring 0.1mm or larger in caliber or showing clinical or radiographic involvement of nerves without invasion of the skull base) or with deep invasion. Deep invasion is defined as invasion deeper than the subcutaneous fat or a tumor thickness \>6mm. The scalp has a natural anatomical and oncological barrier for extension in depth known as the epicranial aponeurosis, also called the galea aponeurotica.

This retrospective study, examines the tumor- en surgical characteristics of these stage T3 cutaneous squamous cell carcinomas on the scalp.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* metastasis by diagnosis
* stage T1/T2/T4

Primary outcomes:
measure: Surgical characteristics
timeFrame: Between 2010-2017
measure: Tumor characteristics
timeFrame: Between 2010-2017
measure: Patients characteristics
timeFrame: Between 2010-2017
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Ellen Oyen
Study officials:
affiliation: Maastricht UMC+
name: Nicole Kelleners-Smeets, dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.