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Investigation of Desmoplastic Squamous Cell Carcinoma (DesmoPEK)

Primary Purpose

Squamous Cell Carcinoma of the Skin

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Immunohistochemistry using Pancytokeratin Staining

About this trial

This is an interventional diagnostic trial for Squamous Cell Carcinoma of the Skin focused on measuring squamous cell carcinoma, dermatosurgery, immunohistochemistry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UniversityhospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Immunohistochemistry

Arm Description

Patients are investigated using immunohistochemistry with Pancytokeratin

Outcomes

Primary Outcome Measures

Recurrence free survival of patients with desmoplastic squamous cell carcinoma (SCC) diagnosed with immunohistochemistry .

Secondary Outcome Measures

Reduction of local recurrence with immunohistochemistry

Histological pattern of tumour growth (continuous versus discontinuous)

Dimension of the tumor spreading according to histological work-up (measured in mm)

Presence of perineurial and perivascular tumor invasion according to histological work-up

Full Information

NCT ID

NCT02717936

First Posted

January 27, 2016

Last Updated

March 24, 2016

Sponsor

University Hospital Tuebingen

1. Study Identification

Unique Protocol Identification Number

NCT02717936

Brief Title

Investigation of Desmoplastic Squamous Cell Carcinoma

Acronym

DesmoPEK

Official Title

Prospektive Therapie-Studie Zur Behandlung Des Desmoplastischen Plattenepithelkarzinoms

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Tuebingen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of the Skin

Keywords

squamous cell carcinoma, dermatosurgery, immunohistochemistry

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immunohistochemistry

Arm Type

Other

Arm Description

Patients are investigated using immunohistochemistry with Pancytokeratin

Intervention Type

Procedure

Intervention Name(s)

Immunohistochemistry using Pancytokeratin Staining

Primary Outcome Measure Information:

Title

Recurrence free survival of patients with desmoplastic squamous cell carcinoma (SCC) diagnosed with immunohistochemistry .

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Reduction of local recurrence with immunohistochemistry

Time Frame

4 years

Title

Histological pattern of tumour growth (continuous versus discontinuous)

Time Frame

4 years

Title

Dimension of the tumor spreading according to histological work-up (measured in mm)

Time Frame

4 years

Title

Presence of perineurial and perivascular tumor invasion according to histological work-up

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Universityhospital

City

Tübingen

State/Province

Baden-Württemberg

ZIP/Postal Code

72076

Country

Germany

Individual Site Status

Recruiting

Facility Contact: