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Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05987579
Collaborator
(none)
104
Enrollment
1
Location
37.9
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    104 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp
    Actual Study Start Date :
    May 3, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Surgical characteristics [Between 2010-2017]

      Choice of treatment, complications, reconstruction types

    2. Tumor characteristics [Between 2010-2017]

      Histological data on invasion depth, tumor differentiation

    3. Patients characteristics [Between 2010-2017]

      Risk factors, comorbidities

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ellen Oyen Maastricht Netherlands

    Sponsors and Collaborators

    • Maastricht University Medical Center

    Investigators

    • Principal Investigator: Nicole Kelleners-Smeets, dr., Maastricht UMC+

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05987579
    Other Study ID Numbers:
    • 2021-2706
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Aug 14, 2023