## Protocol Section
### Identification Module
**NCT ID:** NCT05987579

**Brief Title:** Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp

**Official Title:** Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp

#### Organization Study ID Info
**ID:** 2021-2706
#### Organization
**Class:** OTHER
**Full Name:** Maastricht University Medical Center
### Status Module
#### Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-19

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-18

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-05-03

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2023-08-14
**Type:** ACTUAL
**Study First Submit Date:** 2023-07-20
**Study First Submit QC Date:** 2023-08-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Maastricht University Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Squamous Cell Carcinoma

- Surgery

- Cancer Head Neck

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 104

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Choice of treatment, complications, reconstruction types

**Measure:** Surgical characteristics

**Time Frame:** Between 2010-2017

**Description:** Histological data on invasion depth, tumor differentiation

**Measure:** Tumor characteristics

**Time Frame:** Between 2010-2017

**Description:** Risk factors, comorbidities

**Measure:** Patients characteristics

**Time Frame:** Between 2010-2017

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Maastricht

**Country:** Netherlands

**Facility:** Ellen Oyen

#### Overall Officials

**Official 1:**

**Affiliation:** Maastricht UMC+

**Name:** Nicole Kelleners-Smeets, dr.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### 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.

**PMID:** 28094848

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000018307

- Term: Neoplasms, Squamous Cell

- ID: D000009371

- Term: Neoplasms by Site

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: HIGH

- As Found: Cancer Head Neck

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: HIGH

- As Found: Squamous Cell Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M20451

- Name: Neoplasms, Squamous Cell

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000002294

- Term: Carcinoma, Squamous Cell

- ID: D000006258

- Term: Head and Neck Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
