Investigation of Desmoplastic Squamous Cell Carcinoma

Squamous Cell Carcinoma of the Skin Clinical Trial

— DesmoPEK  

Official title:

Prospektive Therapie-Studie Zur Behandlung Des Desmoplastischen Plattenepithelkarzinoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02717936
• Other study ID #: DESMOPEK1
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2016
• Last updated: March 24, 2016
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: January 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Eberhard Karls Universität Tübingen Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Aim of the study is to verify wether it is possible to have a more sensitive diagnostic tool using pancytokeratin immunohistochemistry for desmoplastic squamous cell carcinoma compared to regular H&E staining. The investigators therefore plan to include 73 participants with a confirmed diagnosis of desmoplastic squamous cell carcinoma and do regular follow up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: January 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• desmoplastic squamous cell carcinoma (SCC) of the skin

Exclusion Criteria:

• tumor recurrence

• collision tumors

• other skin malignancies

• progeria

• Rothmund-Thomson-Syndrome

• lacking of the capacity for informed consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Skin Neoplasms
• Squamous Cell Carcinoma of the Skin

Intervention

Procedure:
• Immunohistochemistry using Pancytokeratin Staining

Locations

Country	Name	City	State
Germany	Universityhospital	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival of patients with desmoplastic squamous cell carcinoma (SCC) diagnosed with immunohistochemistry .		4 years	No
Secondary	Reduction of local recurrence with immunohistochemistry		4 years	No
Secondary	Histological pattern of tumour growth (continuous versus discontinuous)		4 years	No
Secondary	Dimension of the tumor spreading according to histological work-up (measured in mm)		4 years	No
Secondary	Presence of perineurial and perivascular tumor invasion according to histological work-up		4 years	No